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94TdSOxFn7XKTTifS0gP04n7hWeP9sQ9IO499FvWOLTSGalVsV3UUCeL3/nE4bHXAGifgB4A6I2MtmyKIu2LULHpIteVM2fGXivFwo1AKXt1bx/FNcDkmWrURcCqvXFxbmR9z9wr8tWrVYe+VQpMYvePclf+DlHcd1yX+i9jHBqTPewR3q6Y6Dq0STUxeVXHLYD5ENADAL1RrxxtSwzWDV5z7PnFzwdVzIz3quA2O4HodXEu+SzWFp9N26vobS0wP7ZKgc2LyVzuFe2LyUM7D1tF33dtj0PjZ9/14rC7RGWJz3koHXmuj0EPjb0OQI4FnzMA0CexeuGDbz/S+DuKQXpXiiJXz56trrx3plo5tzj6/y+fOjUafMdK7dF/PnB/8XvMRYvBKGaef/mVsb/rox2PCechy52HD1fLzz7Xyr/tjocP2lpgzuqtUoZy/4Bp6dyTJyb5fnzkteqTpaWhvOVBamscGuO3mLzcBSuL71dXz5wZjUXD1RtdzOqOYdu+dn0bptI7Xt31oxdaOZaliUlaO3br8AEwLwJ6AKBXojAfqyPrcLoJURT5wq9+WfTHdPn06erC0derSydOrl/8O3Hy0/8a72n7KEh6ehSGlyhCrgvHjjV6LEu187B9/yBLTIhpI6C/XkC3tUAJ4v4Rk9Munzo99I9iJnFOZ+2rPKurZ86u//zDmFg9X+rzXx9FGBn3no9efW3oH0WvtTEOrW5sm1Py9zVC+Y+PHKkunji5/nuvx6EvX/+PmNC484nHi500Hr9XXCcvHD029nd9414AMD8CegCgd5peHRkruUsduEYwf/7Hr0wcQkQROwoO8SeKD7tfeqHIlQxRkOr76oXbH9ivMAKJ4loXheGLqyYtNSGuV6WvCBuSWG3454e+IbSdQaysu/vXxzvxu/7xv/9lVTnWm9aVzj3XlperK2fOVFff+2wCRgSgoz9793Xq+SkmYwro+6/pcWg8r5S6bU4E89GtZpoQO57B4k9MAov7dYnf5ZjIvuHkdwCYkYAeAOidWBleNZFNVgkAACAASURBVFQYiRZ8pbYr/vC55xsp9EVRJVYafvFXvyxuL9J6P8c+r4K0VzXki4lJTQb0JRfQ1xPBV3wGdSvaegXy9eDr+j791ycQ7Ru1pO3aXtVR7I/ielvbGVCO2Npn3VWbjInveOlbHcUE1I9ffe2W1+m6I1QXrsFxTYpxxZUbLb/ppybHoXF+3/XSi2Ovl+DjI/8wCudnDa9jjBeT6e566YVqx6GyJg4Nbcs1APIJ6AFggGK2+8riuVExc3VBs16RUnrR7laaLIDF/nOliVAlVpU3WeCL8yB+5t1vHC8uhGlrP0eobgQ7UVy8/PbnJ4FEINm11XlNWu8+EYHtlj27O3+faLJtd9da299qxdvqY756clQ8H+w4dKhTrbF3Hv7O6H0KxPrt4m82DnH5vAizSxXPuEvffXLTE6hWd4SKa1Rci0u+P8X188rAJw3VXRGMQ2+t1C5uS9/7+3WfIaYR3+P43ofSQvo7n3i8+vjIa1bRA9AKAT0ADESEUDGQ3nBvuFVGK1EePljcIHmzIlybtTASAU5pRaI2wvlaFB5KDOmHsIqeXBeOvT5qWblhAHBjj8woFo/2yTx8uPdhfdwnoitHdNTY7H0iwoYudoGIVvRNXVeigN6F1vZx/4hgftrOK3FOxD8ff2JlehStu/C+Y6KdSV79dmmjazljth04MPZaCWZ9xq0nm8b1qdTuVzE+GaKhjUPjd591rBbPn3GfLU3T4fxqJYb08ZxjFT0AbbnNJwsA/RYFkQ/++pHqT1//xqgov9kWoFFAiUFy7OkZbSa7poniY+yHV5rlZ59vdSXgaAXD3z05KpKW5M4nDhd3LOieaMf5f//rf5todV5cM+Pa+cev/sVoW4nSvhtNiGt8fZ+Iousk94n//Ju/Hf2zca/pmibuE1FALzUIWi2Oz58e+kZj+x9HoTqCsC4c95jkVfKKYWYTHSF0SJhMkx1EmhTXlSaOZfycuN+XKCbAxn1jKAY7Dm1gIkZMNCltElx8r9oK52sfPvv86LpekpiMCgBtENADQI+df/kno4LILCsE69Uo8bO6ZNbiY4ktfC+dfLP1okiI4mhpqwRihe6QCpo0K0L1Pz/0zdFe1LO0qIzicldCyc2Ka3u8p1nuE/HPjsL9Y6+P/V3Jmiqgl24UkHz7kcb36I57RVe+D6Xu4cvsrJ6fTDxLldj5ou7g0pS435cW8tWi/fkQDHkcOusxvr6lTFndA+rtcdp2vd399+b9dj8nagJCegDaIKAHgJ6K9nNNDqLjZ8Xq0a6I4uMsge6Ox8oqikTAuJy4Z2UUSUsLXWLvY5hUnMd//OpfNrbCskuh5K00fZ+I1W5dCun7WEC/WR3Ot7V3ar01SunfB8X1/rp44sTQP4KJbN1b5mTHJsP5WqktqRcGENC3MQ6Nn9kVs45D7zxcXuewCM2z9mGPSR2ldcEorTYAQD8I6AGgh9raGy6KZ10KX6YtQpa49/wkbSGbsvyDvAkBmyFcYVL1frZNFxRL3QpiEm3dJyKk70o72llXkZa+ej7OzzhP2y6ox8+PrQ5K/z6UuJcvs4lzbpbVuUNU6v7zbXRCiHtcidelvu9D39bzRfzMIYxDb9uzp7gwOJ7rsq+1MSmjpO9v1AZ0cwOgaQJ6AOiZKFy02QY99oXrSih1+wPTrVApMQi+cKz91vY3i0JMSUFbrIC0jzCTiNCwrXCyxK0gNqvtPUQjpO/KfWLa7VCigF769aip/Zw3IyaQxXEvWez9XOre20znovb2vRCts9u6V5c4gaPPLe7b3o6rxP3J1zPtZJjtDx8sb+/5Fjpc3EpcE9rorDEL41AAmiagB4AeiUAkChdtisHycsv/jqZs2b1n4p80WrVQWMviKHZlr56vnf9xYXvRK4ywSTFZqe3C/KizRUcKxbW4T7Q9sSCuV6UVVZsWq9tK3Me5Fudl9jGIsLT07gk6sfSL/ecnV+IK0JXFc2OvNeXyqVPZb+eWSr53zGLUtaXliVoxDu3q5MjNKq3bSzxPzGsy1MdHXitqwqdnCACaJqAHgB6JgkXG3nCxMqILoVSE7ZMqMQBucyXKrUTAWdLewlYusBkZk5VqXSsUxwSrjPtEaUXV9UzbaWVngfvDrhZ7xc7Dhz8oewJfTMCb5tmA8sT1xQr6yQ2tRfOV93K6iEyqj6voY1KYcehnpnm+iPMiur2UZJ4ToeJ8Kuk6H8dGm3sAmrTg0wSAfohC5YWjefvyRXFk1zNPjb1ekoUHJi9wlLhH7bzbc8axvuvFF8Zen4dYdRTFq6y2zXRTFPMyisTVje/H7pde6MSKuLhPZBVa4/OPe9LOw98Z+7uSTNNpJa5BseVGqSK4mNd9I67NsYo+9motVXQ/6HuHhyGw9zybcW2pzIliW/b0axV9PF/ExLwsHx85UszYZD3THOMSV2hfPHFi7LVM0V6/pO52MVncM8TG4jk0OqNcfe/sp+OxlcXFauXceLeUmMgyzbM4QF8I6AGgJzIDqerGnuilB/STihnxpa1aiKAj87iuJc6tkopg0eVAQM9GsvfK7EIQXd34PVPvE0ePdeJzmVTpLU7n3dUhtka5+9fHx14vRRw/xfXus3q+P2JCT3S2aOP+5HkxR/Y4tLSxSVNK6+QWEy/mPRkqvsMR+JYyMXK7gH5MdNu7/Pbp0ZYicb5Mci0w2Q4YOgE9APREdvu52GO4pMFyE7YdOFDc7xSD3Xkr7Vjf8VcHe7//5CyimDYqZsVxO7c4+knXlpfWbfMaRfGFG61WS9yrdVJxrmYX5ONz60IQnb0KqrSialNK3ApltXnvyx3F1pKPe92itr4+0k32n++XnYcfH9Sz3dZ9+6qqR8HUPMahEQqWNrF6FiV25yllgks8Z5eyir7kDkGZ6u6NHx054nkKYAYCegDoiXmsJIpiTJ9WR5a4v3kpgWlJhZEoxrW10qqLZlm18KkeBR3z+M50ZSXnPFaplHTtaELp7e0vnXyziGtj6c8HWtR2WynneRdFy+ESA6boyhXXjTYCwehGRbvm8RwUz759Cui3fa2872UJE8WrG8+vJT1Lbjvw4GBXfkcwv/zs86MuWQDMTkAPAD0wr8JT39pGxmC7NFfPnC3iNyqtMLKw//5Bt8SL1amx/2YURK1a+Lx5nRel77s9r/vE1dF9oj8Bfemr50uZLFL69gZa1Hab9vbTK3liw91vHK+Wvvtk48f3g28/MvYazTEObUaJzxdXC/mMr67TBWxeouveEMehHx/5h1GnExPkAJpzm88SALovVsPMw8q5c705e2JV5Jbdu8den6eYoV7KALi0Y13idgQZIphf+t7fV3/86l+MwiXh/Lh5FfFKPxbzWgW13tYKXRVbbJSslK4rEZzEPaxUWtR2Wx+2Y5mXlcVy71XxHP6Ff/rHas8vfjbahoJuMA5tRon3pVKebUubjFFit4M2xfPc//sf/7NafvY54TxAwwT0ANADK4vzKVD0aeZ4iQPtkooRpR3roRVGwvmXfzIK5rUU3Ni8vjelB/TXludTUOvTfSK21ii5nW5sd1HSeVj6sS+xaw63Vtp53jVdCDWjY9N9774jqO+IeQV2vRqHFno/KmksGtf+UsTE/qGIcD66kOhcA9AOAT0A9EDfVijOQ4krsq8tlbv6cN6GVBiJVfN/fuibo5aCbGyeK3ZLX9HpPjG72FqjZKUd49K/E0PtxNJ1JqnNpkuhZh3UR+v7HY8dGk2Sojw6Wszu9gfKG9fE+KMkJa3cjm4fQxiL1uF837aTACiJgB4AmMm89h1s2kKBg+ziwpaCjnUURoawqipWi/z5oW8ojGySz6lMJa16mkXpgW4pe8XWSp8UMsROLH1gFd/sunZNjtbfe37+0+pL//ov1Rd/9UthPZ8yDm3PvDr0rae0zil9H4cK5wFyCOgBoAestJ7d1r1f6fpbGJyte/tdGIkCehRG7PVHE+Z5n+jLOVx6oFveCvqyg5MhdWLpC+3tm3H57e6GmtsPfuvTsP7e3/+u2vXM077LdF6JYW9p9YXSrv0lTqpo0vKzzwvnARII6AGgBwyeZlPqvn+lrYYsTZ/bE8eqhf/8m78VzndI6WGk+8TsSg+Brp4pb1VsaS1yVxtKJ5Y+6XKwXJK+bBOwcP/91a5nnqrueeu31Zf/z//+dHW97zVdE10iSmNrpI2VuC1BUy6dfNN2MgBJFnzQAMDQldomc9f3n652PvH42OvzUlo41ecC7NJ3n7RKEAoS94kIdEsVk3pKnNATLXJL7lATnVhca7tDYNCMmLAVk2f61D0qrs+xuj7+VDcmB8Xe6JdOnBxNoDPhkVKVOp6JyS4ldQ7aunff2Gvz1Odx6PKzz429BkA7BPQAwOCV2qIuVgaxvr4WRmLVgj12oSwL+8u+HpfaIeHqe2eLXBlYi04spXe/4LoIXHUCac75l18ZtYrvq5h8sOPQo6M/1Y3tES7+5uQotPedpySlbtkV3yFbwK2vr+P0C8deN3ERIJEW9wDA4JW6gp6N9XXPUasWaIOWv7PZuq+slVtdUfqqVff/7rhk4lqjohtBdN4Yirod/t2/Pq4dPkXxfNFdfbx+xOQtAPII6AGAwVt4wEr1Liq53fS0rFqgLaWu0OqK0j+/UvfmXlks+3rm/t8dsfKZZi0/+/wgP9G6HX50ELjv3Xeqe3//u2rXM0/3duInZfN81l19O3bGoQD5BPQAAHRW31YuWLUAZbLKcjor584V/ftZQd8NsdLb1i/Ni1X00fp96OrV9fe89dvqvn/+Q7X7pReF9cAt9e0ZQqcagHwCegBg8Lbu1Vqwq/q0ciGK5FYtQJkE9P3U1z1k+0Y4356lv3uyr29tKrHn9s7D3xHWk+b2B5xfXbXQo2uDiXAA8yGgBwAGL4pxMG+xkg1gGqW2/762NJw9rmmPVX3tuXLmTPXhc8NsdX8ra4X1JmvRtC17+rdlF90jnAeYjwWfOwAAXbXtwIHq8qky916elMIIlGvbgw86OlOI8K90EbjpXrK26Oyy/IPn1vy7TH25z5fqo1dfG60E3XHo0aF/FOuqw/r4c+nkm9VHrx5xXsLA9an7gesZwHwI6AEAYM5WFt8XEAHMQWyV4vq7tk+WlhTtB2Lpu9db3Qvpb237wW+N/lw+fbo6/+NXfEdgoPrU/aDUTkwAfafFPQAAzNnVDqwyBQD6K0L6C8ded4Q3KTqr3P3r49XdbxzX+h7orNh/3kRFgPkQ0AMA0Fl9aS145T0BPQAwX0L6yUVQf9+771S7nnm6a786MIPb9uzpxcfXhe2IAPpKQA8AQGf1pbWgtoIAQAkipP/wuecdiwnteuap6t7f/666fX9/9qUG1rdw//3r/l2XXH3vrKMMMCcCegAAmLNrS8sOAQBQhI9efa3680PfrFYW33dAJhCBXbS8v+Phg535nYFh+2RpaegfAcDc/H/27ie2rvLOG/gJdhwSEpu/7bvAWXTU2cRZ0LKykYrohmQkKlYkCwqbEqQC3VBGmoRFleSV3sCmQCUCG2gWhBVqpUnYFDESyYqWRZzNjGYWMdJMh0KxCYQ4dvPqd5JDjW+c2D7nPvc5934+kkV7Esy9555773me7/P7PQJ6AADoMa0FAYCcxL3Jp/c/UHx19HWvyxpsGB0tbv3tG8XmvXta85iBwbVgHArQMwJ6AAAAAOBborJybv+B4rOfPFzMnz7t5KzB2Mu/FtID2VNBD9A7AnoAAFrrprGx1r94JrwBgJzNnzpdfPbQw8Xs07/Q9n4NhPQAAKxEQA8AQGvFXp8AAHTfhbeOF5/c80NB/RpESD8yNdmaxwsMlliABUBvCOgBAAAAgFWpgvrPf/q4TkCrcNuxN/ui6xPwbRbfAFCHgB4AGHiX5+YG/RQAAMCafH3iZNn6/pMf3Ft8dfR199Qr2DA6Woy98tK1/xAAgIEkoAcABt6l6elBPwUAALAui+dmirn9B4o/f+/7ZVX9xZPvOpHLbNr1YHHz7l0dxxlsC2fODvopAICBJaAHAACA61AVuj5taOm8MC0cgSZFVf1fH32s+N9/+Mdyr3ph/d9tO3yo4xiD7W+zs4N+CgBgYAnoAQAA4Dpy77SycedEx7EcDE/syPJxLSUcge6I91bsVb80rL9w/O2BXvA0NH53sXnvno7jAAAMnmGvOQAw6KItZzGZ10k4f+TF4vyRFzqOA8ByG0bzr1QHBlcV1sdPLIkZmZosbt69u9i0e1cZWg+Src/9sjwPUJQdevJbJDZ/+nTx2UMPdxwHAJqlgh4AGHhlQA8AK/A90Z8ihADSmz91utyz/pN7flh88oN7iy8OPD8wrfBjQUIsUIBw6UzeHXoAgO4R0AMAAMB15B7QD20f7ziWg1xb7wP5iM/XL199rWyF/z93frf4/KePl63wF2c+7ttXSZt7AAC0uAcABt5ChnsL5xq2AAyixRkB/Xrk3np/4czZjmNAb3194mT5EzZOTJRh9sh9k8Xwjh1988rcvHtXkV9jc3oh9/sLAKB7BPQAwMCLfTFzI6AHyMfiuXNZvxo3jeUZhOf+XZbj9z/wd5emp4tL+w+U/z8+TyLY3rJvX+v3rd8wOlouPriU4SJh0sqxQ09cmwBA92lxDwAMPJULAFzPwnTelda5VpbmHtDPnzrVcQzIU9UKP/at//T+H5dt8C/PzbX21YquABByu45jAQkA0H0CegBg4OW+tzAAvRWV1rnvh5xjGD40vr3jWE4s0IN2isrz2aeeKT65595i9ulftHK/+pGpqY5jDCadFABgMAnoAQCiOvJsXtWRWgsC5GVxJu8290PjOQb0+bahjopFC/Sg3WLx1IW3jpdV9W0L6m1nRSXH76Jct84BgH4ioAcAyHAfWq0FAfIy/8HprF+R3KoxR6bybt+sYhH6SwT1n97/QPHV0ddb8bxy3ZqE9HIM6IcnXJ8A0G0CegCATIMXlTUA+ch9v/LcvjM27sy7E0zuCy6AtYsFt3P7DxSf/eThVuxP716fItP7CxX0ANB9w84xAEBRLGRYSRftinOpqIhJmhwrKeZPCViANBam89oKZbncKuiHM9+qJfcFF8D6xf3hZw89XNz++3ey7kqV070+vbM4k2MF/URRnDjZcbxXcuzKE/eFuXXhA6BdBPQAAJm2FoywJZcAOsL523/3TsfxXvufO7+b3WMC+lNMwi6cPZttW+LY7z2qMXP5PsttwcByFngxaCLgyvF9ef7ICx3HmhDbWLQhpIf43o6ODzldp7l1wclxHBqdOtxLAFCHgB4A4OoknomRlQ1t377inwEMimiLnvO+wRG+XTh3vON4arFQIBYM5Gr+tAl1Bk98Pmx97tnsnne3Avri6v19/P5thw52/BnkJK7Vkcl8qsRz6oKzMdOOPJdn899GA4C82YMeAOCqS5m1uTcxcn0CFiC1r0+cyPqc59IC9ubduzqO5eRiRm17YZCluJf78tXXisWZjzuO5yC3KmV6JxYA5qTqypODXB7HcrnNHQDQPgJ6AICrTIysbOS+/Pb9U7UApBatTKPbSq5yCcY3793TcSwnXwvoYaB8dfRolk93w+hYxzEG0/ypU9k971y2xMhxa45cF/0A0C4CegCAq3KcGMkhbLlpbCzLls6XzqhaANLLOdyNbVp6HY7HwrKctwGISfVc9umHQZeqQ1Ou94yX52Y7jjGYctzLPJdFf5sy7MqzoHoegAYI6AEArspxYiSHKsQcJ0WKTBdUAP0v9/bom/c+0nEspVv27evpf/9Gcq2khUEUi4pSyPEev7DYlGVy275r064Hy4XavRSLeKKrXG68dwFogoAeAGCJiyffzep0RBVir/d/v+XJJzqO5SDXyVagv0UFfc6tTUcmJ3u2F31M5Pd6gcCNaG8PeenV5xXkJscFgL1eqJ3rljkWigPQBAE9AMASOU7cb+lhQB6Tpjm2Ks6twgQYLBfeOp718936z7/sOJbCln1PJKuIXY/47tDenkGVa0vmm3fv7jjWtNh6A3I3/0F+45utz/XmfqLIeNHf5bk5C8UBaISAHgBgiRxXw2/e80jPJhZ7FfLcSO4tpoH+duF43gF9L6ro43sq144rlQtvvd1xDAbF32bz3O88RYVur7tRrWRh+uwKf8IgujQ9nV2Hnmgv36sq9lwX/QnnAWiKgB4AYImorFs4m99k2ejhQx3Hui2Clgh5cqRFMdBL8V1x4XjeYe/YKy8n3Ts2vqdyrp6P0CP3zgfQTYszeXaPSBEAjkxNdRzLQa6LJuidHBchRxV96r3oY1HN1uee7TieA+NQAJoioAcAWObLV1/rONZrm3Y9mLR64cqkSJ7V87GAQotioNdyD3sj9Bp75aWO490QC7rieypnXx09mvXjg27L+d6pmwFgrm2ybdfEteR4bxH3EynHhfGeHftNmvuXtYr29jq5AdAUAT0AwDIx6I7Bd25GDx9M0qKzmhTJtRIyxwUUwOCJFqe5BywRmnc7pI/FY9sOHew4npP4TtfeHvINhSMA3Ha4O58jubbJttiUa4k29zl2c9uy72fJFovHfcvwjh0dx3MQ1fM6XwDQFAE9AMAyMejOsXVdTC7e/vt3uhrSxx7C8d/IdVJE1QKQk/P/74XsX4/Nex7pWkgfk/VjL/+643huzh95wYQ6RBeiM/nueR6fVU0HgPH7cm2TbR9rVpLrYuT4vu9mSF8uEn/lpaw78nxloTgADRLQAwBcQ66D7yqkH5lqfm/4m3fvKu58/71sw/ni6oSVkAXIRQQsF0++m/3rEcFXfHfEIqwmxCR67DnfhnA+9p7XeQWuiOrcnMVnSmyZ0YTcFxDNnzrVcQyKq23uc+zmVnQxpI8F6HGfEvcruYoOJLl/hgLQLgJ6AIBriMF3rm1Ay5D+d+80tl9nBDa3HXuzuPW3b2Tb1r64Wj3/1VEhC5CXuf0HWvGKjExOlouw6n53xMT8He+/V7a7bYMvWvL6QAptCIVjy4y4L13v51R1X5tz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aria-current="page">Regulatory Affairs for FSP</span></span></div></div></div></div> <div class="wp-block-emagine-columns alignfull"><div id="em-layout-id_f22cbd-87" class="em-row-layout-inner em-margin-top--default em-margin-bottom--default em-tablet-margin-top--default em-tablet-margin-bottom--none em-mobile-margin-top--default em-mobile-margin-bottom--default em-layout-id_f22cbd-87"><div class="em-row-column-wrap em-has-2-columns em-gutter-default em-row-valign-top em-row-layout-left-golden em-tab-layout-inherit em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--default em-tablet-padding-top--default em-tablet-padding-bottom--default em-mobile-padding-top--default em-mobile-padding-bottom--default alignwide"> <div class="wp-block-emagine-column emagine-column5001 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--medium em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none 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management, our cross-functional regulatory experts bring unmatched expertise and insights, a scalable approach and leading-edge systems. We help you navigate global regulatory environments, accelerate outcomes and increase the probability of approval success.</p> <div style="height:1rem" aria-hidden="true" class="wp-block-spacer"></div> <div class="wp-block-emagine-button"><a class="wp-block-emagine-button__more has-purple-background-color block-btn block-btn--sm block-btn--primary" style="background-color:#633a97" href="#contact-ppd" rel=""><span class="block-btn__hover" style="color:#fff;background-color:#4f2683;border-color:transparent">Contact us to find out more about our FSP Regulatory Affairs solutions</span></a></div> </div></div> <div class="wp-block-emagine-column emagine-column275 inner-column-2"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none 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<li><a href="#expertise-and-commitment">Unmatched Expertise and Commitment to Quality</a></li> <li><a href="#end-to-end">End-to-End Regulatory Solutions Provide the Ease of a Single Partner</a></li> <li><a href="#support">Support for All Clinical and Peri- and Post-marketing Needs</a></li> <li><a href="#cross-functional">Cross-Functional Experts Increase the Probability of Success</a></li> <li><a href="#global-reach">Global Reach and Specialized Expertise</a></li> <li><a href="#proven-systems">Proven Systems Provide the Foundation for Successful Submissions</a></li> </ul> </div> </section> </div></div> </div></div></div> <section id="cta-block-block_79c5948842a441d13efaae7ef203958e" class="cta-block alignwide dark-text has-green-background-color" > <div class="inner aligndefault"> <div class="cta-block__body"> <div class="cta-block__content"><p><span class="h4">Regulatory expertise to increase your probability of approval success.</span></p> </div> </div> <div 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emagine-column7165 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"> <h2 class="wp-block-heading has-text-align-center aligndefault">An unmatched level of expertise and commitment to quality</h2> <div class="wp-block-emagine-columns alignfull alignundefined reduce-countup-spacing"><div id="em-layout-id_7fb822-0e" class="em-row-layout-inner em-margin-top--xlarge em-margin-bottom--default em-tablet-margin-top--xlarge em-tablet-margin-bottom--default em-mobile-margin-top--default em-mobile-margin-bottom--default em-layout-id_7fb822-0e"><div class="em-row-column-wrap em-has-4-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-two-grid em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--none em-tablet-padding-top--default em-tablet-padding-bottom--default em-mobile-padding-top--default em-mobile-padding-bottom--default alignfull"> <div class="wp-block-emagine-column emagine-column1487 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--xlarge em-tablet-padding-left--none em-mobile-padding-top--xlarge em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="countup-block-block_496f5edea7ec5093326494221e27a99c" class="countup-block alignfull"> <div class="countup-block__wrapper purple"> <div class="countup-block__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2021/03/icon-best.svg" alt=""> </div> <div class="countup-block__content"> <span class="countup-block__number" data-number="30">0</span> <span class="countup-block__before">+</span> <div class="countup-block__label"><p>30+ years of regulatory services experience</p> </div> </div> </div> </div> </div></div> <div class="wp-block-emagine-column emagine-column6082 inner-column-2"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--xlarge em-tablet-padding-left--none em-mobile-padding-top--xlarge em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="countup-block-block_469e5d98aea1350b248dc7e250dc361d" class="countup-block alignfull"> <div class="countup-block__wrapper purple"> <div class="countup-block__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2022/09/icon-web-localization.svg" alt=""> </div> <div class="countup-block__content"> <span class="countup-block__number" data-number="160">0</span> <span class="countup-block__before">+</span> <div class="countup-block__label"><p>Successful preparation and management of regulatory submissions in 160+ countries</p> </div> </div> </div> </div> </div></div> <div class="wp-block-emagine-column emagine-column7667 inner-column-3"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--xlarge em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="countup-block-block_be9780f8d5800f8257079a445351428c" class="countup-block alignfull"> <div class="countup-block__wrapper purple"> <div class="countup-block__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2020/10/icon-group-people.svg" alt=""> </div> <div class="countup-block__content"> <span class="countup-block__number" data-number="24">0</span> <div class="countup-block__label"><p>Senior staff average 24 years of pharmaceutical and medical device experience and 18 years in regulatory affairs</p> </div> </div> </div> </div> </div></div> <div class="wp-block-emagine-column emagine-column9418 inner-column-4"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--xlarge em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="countup-block-block_b70ea6ce057373f69583007bf7a37db7" class="countup-block alignfull"> <div class="countup-block__wrapper purple"> <div class="countup-block__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2021/02/icon-china.svg" alt=""> </div> <div class="countup-block__content"> <span class="countup-block__number" data-number="400">0</span> <span class="countup-block__before">+</span> <div class="countup-block__label"><p>400+ successful regulatory approvals or licenses In China since 2000</p> </div> </div> </div> </div> </div></div> </div></div></div> <h3 class="wp-block-heading has-text-align-left" style="text-transform:none">Proven track record of success</h3> <div class="wp-block-emagine-columns alignfull"><div id="em-layout-id_2c9735-23" class="em-row-layout-inner em-margin-top--small em-margin-bottom--default em-tablet-margin-top--none em-tablet-margin-bottom--default em-mobile-margin-top--none em-mobile-margin-bottom--default em-layout-id_2c9735-23"><div class="em-row-column-wrap em-has-2-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-inherit em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--none em-padding-bottom--none em-tablet-padding-top--default em-tablet-padding-bottom--default em-mobile-padding-top--default em-mobile-padding-bottom--default alignfull"> <div class="wp-block-emagine-column emagine-column4609 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--medium em-mobile-padding-left--none"> <p class="has-text-align-left mb-0">In the last five years, we’ve supported:</p> <ul class="wp-block-list"> <li>50+ new drug applications/marketing applications</li> <li>140+ agency meetings</li> <li>Nearly 900 new market expansion licenses</li> <li>5,950+ clinical trial applications/investigational new drugs</li> <li>34,900+ lifecycle submissions</li> <li>54,200+ clinical trial applications/investigational new drug updates</li> </ul> </div></div> <div class="wp-block-emagine-column emagine-column6759 inner-column-2"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"> <p class="has-text-align-left mb-0">And we delivered:</p> <ul class="wp-block-list"> <li>99% first cycle approval</li> <li>Zero licenses lost or compromised</li> <li>Zero dossiers failing validation</li> <li>99% submission milestones achieved</li> </ul> </div></div> </div></div></div> </div></div> </div></div></div> <div class="wp-block-emagine-columns alignfull" id="end-to-end"><div id="em-layout-id_78db43-fd" class="em-row-layout-inner em-margin-top--none em-margin-bottom--none em-tablet-margin-top--default em-tablet-margin-bottom--none em-mobile-margin-top--default em-mobile-margin-bottom--none em-layout-id_78db43-fd"><div class="em-row-column-wrap em-has-1-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-inherit em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--none em-tablet-padding-top--xlarge em-tablet-padding-bottom--none em-mobile-padding-top--default em-mobile-padding-bottom--none aligndefault"> <div class="wp-block-emagine-column emagine-column9333 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"> <h2 class="wp-block-heading has-text-align-center">End-to-end regulatory solutions provide the ease of a single partner</h2> <p class="has-text-align-center">PPD FSP Regulatory Affairs solutions provide strategic and technical services across the full product life cycle and all product groups:</p> </div></div> </div></div></div> <div class="wp-block-emagine-columns alignfull mobile-hex-icons"><div id="em-layout-id_879c77-b9" class="em-row-layout-inner em-margin-top--none em-margin-bottom--default em-tablet-margin-top--none em-tablet-margin-bottom--none em-mobile-margin-top--none em-mobile-margin-bottom--none em-layout-id_879c77-b9"><div class="em-row-column-wrap em-has-3-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-inherit em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--default em-tablet-padding-top--default em-tablet-padding-bottom--default em-mobile-padding-top--default em-mobile-padding-bottom--default alignwide"> <div class="wp-block-emagine-column emagine-column1056 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--medium em-padding-bottom--none em-padding-left--medium em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><section id="hexagon-listing-block_d9f3b4c429adce3417851f5aae4428bb" class="hexagon-listing aligndefault hide-border"> <div class="hexagon-listing__item"> <div class="hexagon-listing__icon purple"> <div class="hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2021/08/icon-gmp-wide-range.svg" alt=""> </div> </div> <div class="hexagon-listing__content center-align "> Advanced therapies </div> </div> <div class="hexagon-listing__item"> <div class="hexagon-listing__icon purple"> <div class="hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2020/06/icon-lab-bioA.svg" alt=""> </div> </div> <div class="hexagon-listing__content center-align "> Biologicals </div> </div> <div class="hexagon-listing__item"> <div class="hexagon-listing__icon purple"> <div class="hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2019/10/icon-Icon-Virus.svg" alt=""> </div> </div> <div class="hexagon-listing__content center-align "> Biosimilars </div> </div> </section> </div></div> <div class="wp-block-emagine-column emagine-column2435 inner-column-2"><div class="em-inside-inner-col em-padding-top--none em-padding-right--medium em-padding-bottom--none em-padding-left--medium em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><section id="hexagon-listing-block_32e494292fd07bdc0c4de43a5302b561" class="hexagon-listing aligndefault hide-border"> <div class="hexagon-listing__item"> <div class="hexagon-listing__icon purple"> <div class="hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2020/11/icon-man-woman.svg" alt=""> </div> </div> <div class="hexagon-listing__content center-align "> Consumer </div> </div> <div class="hexagon-listing__item"> <div class="hexagon-listing__icon purple"> <div class="hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2020/06/icon-lab-gmp.svg" alt=""> </div> </div> <div class="hexagon-listing__content center-align "> Generics </div> </div> <div class="hexagon-listing__item"> <div class="hexagon-listing__icon purple"> <div class="hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2021/08/icon-standard-care-6113ef38ad8ec.svg" alt="Standard of care"> </div> </div> <div class="hexagon-listing__content center-align "> Medical devices and diagnostics </div> </div> </section> </div></div> <div class="wp-block-emagine-column emagine-column9877 inner-column-3"><div class="em-inside-inner-col em-padding-top--none em-padding-right--medium em-padding-bottom--none em-padding-left--medium em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><section id="hexagon-listing-block_20978736658f8e37e669d146eef24e4d" class="hexagon-listing aligndefault hide-border"> <div class="hexagon-listing__item"> <div class="hexagon-listing__icon purple"> <div class="hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2023/10/icon-over-the-counter-products.svg" alt=""> </div> </div> <div class="hexagon-listing__content center-align "> Over-the-counter products </div> </div> <div class="hexagon-listing__item"> <div class="hexagon-listing__icon purple"> <div class="hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2020/03/icon-microscope.svg" alt=""> </div> </div> <div class="hexagon-listing__content center-align "> Small molecules </div> </div> <div class="hexagon-listing__item"> <div class="hexagon-listing__icon purple"> <div class="hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2020/06/icon-lab-vaccine.svg" alt=""> </div> </div> <div class="hexagon-listing__content center-align "> Vaccines </div> </div> </section> </div></div> </div></div></div> <div class="wp-block-emagine-columns alignfull" id="support"><div id="em-layout-id_923eff-b7" class="em-row-layout-inner em-margin-top--none em-margin-bottom--none em-tablet-margin-top--none em-tablet-margin-bottom--none em-mobile-margin-top--none em-mobile-margin-bottom--none em-row-has-bg em-layout-id_923eff-b7"><div class="em-row-column-wrap em-has-1-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-inherit em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--xlarge em-padding-bottom--xlarge em-tablet-padding-top--xlarge em-tablet-padding-bottom--xlarge em-mobile-padding-top--xlarge em-mobile-padding-bottom--default aligndefault"> <div class="wp-block-emagine-column emagine-column4849 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"> <h2 class="wp-block-heading has-text-align-center" style="text-transform:none">Support for all clinical and peri- and post-marketing needs</h2> </div></div> </div></div></div> <div class="wp-block-emagine-columns alignfull cards-center-aligned"><div id="em-layout-id_664448-ce" class="em-row-layout-inner em-margin-top--none em-margin-bottom--none em-tablet-margin-top--none em-tablet-margin-bottom--none em-mobile-margin-top--none em-mobile-margin-bottom--none em-row-has-bg em-layout-id_664448-ce"><div class="em-row-column-wrap em-has-3-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-equal em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--default em-tablet-padding-top--default em-tablet-padding-bottom--default em-mobile-padding-top--default em-mobile-padding-bottom--none alignwide"> <div class="wp-block-emagine-column emagine-column3394 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="ppd-card-block_8c01a7d5fc6907e45740fde7409bdcae" class="ppd-card alignfull no-bottom-card has-hex "> <div class="ppd-card__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2023/10/icon-regulatory-strategy-and-expertise.svg" alt=""> </div> <div class="ppd-card__inner pad-btm"> <div class="ppd-card__top"> <p class="ppd-card__content"><strong>Regulatory strategy & expertise</strong>: Develop global or regional regulatory strategies, identify relevant regulatory designations to expedite product review and approval, and support assets with unique challenges, such as rare diseases, cell and gene therapies, medical devices, biosimilars.</p> </div> <div class="ppd-card__bottom"> </div> </div> </div> </div></div> <div class="wp-block-emagine-column emagine-column6911 inner-column-2"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="ppd-card-block_178c57be861a084eebbb31ca922a643b" class="ppd-card alignfull no-bottom-card has-hex "> <div class="ppd-card__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2023/10/icon-regulatory-intelligence.svg" alt=""> </div> <div class="ppd-card__inner pad-btm"> <div class="ppd-card__top"> <p class="ppd-card__content"><strong>Regulatory intelligence</strong>: Monitor and assess the regulatory environment, review and benchmark competitor products, develop risk mitigation strategies, and create regulatory summary communications.</p> </div> <div class="ppd-card__bottom"> </div> </div> </div> </div></div> <div class="wp-block-emagine-column emagine-column7766 inner-column-3"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="ppd-card-block_94e819c4a08a75941c88cdc1ce7b59a4" class="ppd-card alignfull no-bottom-card has-hex "> <div class="ppd-card__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2023/10/icon-regulatory-science-and-innovation.svg" alt=""> </div> <div class="ppd-card__inner pad-btm"> <div class="ppd-card__top"> <p class="ppd-card__content"><strong>Regulatory science and innovation</strong>: Provide regulatory knowledge to accelerate innovation, improve decision making and influence future paradigms, like adaptive pathways, collaborative design, novel technological platforms and trial designs and advanced therapy solutions.</p> </div> <div class="ppd-card__bottom"> </div> </div> </div> </div></div> </div></div></div> <div class="wp-block-emagine-columns alignfull cards-center-aligned"><div id="em-layout-id_a183e5-aa" class="em-row-layout-inner em-margin-top--none em-margin-bottom--none em-tablet-margin-top--none em-tablet-margin-bottom--none em-mobile-margin-top--none em-mobile-margin-bottom--none em-row-has-bg em-layout-id_a183e5-aa"><div class="em-row-column-wrap em-has-3-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-equal em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--default em-tablet-padding-top--default em-tablet-padding-bottom--default em-mobile-padding-top--none em-mobile-padding-bottom--none alignwide"> <div class="wp-block-emagine-column emagine-column5141 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="ppd-card-block_4d4e492864cbd89dd8f987d095362fff" class="ppd-card alignfull no-bottom-card has-hex "> <div class="ppd-card__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2023/10/icon-market-access-strategies.svg" alt=""> </div> <div class="ppd-card__inner pad-btm"> <div class="ppd-card__top"> <p class="ppd-card__content"><strong>Market access strategies</strong>: Align regulatory and health technology assessment (HTA) guidance, design and implement market access strategies, drive strategies for early access and adaptive/conditional licensing with robust post-approval framework, and build evidence to achieve regulatory approval and support substantiated product value.</p> </div> <div class="ppd-card__bottom"> </div> </div> </div> </div></div> <div class="wp-block-emagine-column emagine-column7718 inner-column-2"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="ppd-card-block_bb87fe93352ed949a5676d8ace815531" class="ppd-card alignfull no-bottom-card has-hex "> <div class="ppd-card__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2023/10/icon-technical-expertise.svg" alt=""> </div> <div class="ppd-card__inner pad-btm"> <div class="ppd-card__top"> <p class="ppd-card__content"><strong>CMC, Non-clinical and clinical technical expertise</strong>: Author and provide scientific review of submissions, annual reports, drug master files (DMF), active substance master files (ASMF) and core registration dossiers, provide protocol assistance, and offer analytical and manufacturing process development consultation.</p> </div> <div class="ppd-card__bottom"> </div> </div> </div> </div></div> <div class="wp-block-emagine-column emagine-column6726 inner-column-3"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="ppd-card-block_9f0aba950e87423d458f8a2938d8debb" class="ppd-card alignfull no-bottom-card has-hex "> <div class="ppd-card__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2019/12/icon_dna.svg" alt="DNA"> </div> <div class="ppd-card__inner pad-btm"> <div class="ppd-card__top"> <p class="ppd-card__content"><strong>Investigational New Drug (IND) services</strong>: Provide strategy development, module and content development, SME review, and IND publishing and maintenance submission, assist with FDA meetings, and support a variety of submissions (e.g., breakthrough therapy designation, orphan drug designation, regenerative medicine advanced therapy designation, pediatric study plans).</p> </div> <div class="ppd-card__bottom"> </div> </div> </div> </div></div> </div></div></div> <div class="wp-block-emagine-columns alignfull cards-center-aligned"><div id="em-layout-id_e57a34-0a" class="em-row-layout-inner em-margin-top--none em-margin-bottom--none em-tablet-margin-top--none em-tablet-margin-bottom--none em-mobile-margin-top--none em-mobile-margin-bottom--none em-row-has-bg em-layout-id_e57a34-0a"><div class="em-row-column-wrap em-has-3-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-equal em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--xlarge em-tablet-padding-top--default em-tablet-padding-bottom--xlarge em-mobile-padding-top--none em-mobile-padding-bottom--xlarge alignwide"> <div class="wp-block-emagine-column emagine-column2934 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="ppd-card-block_04d3b2edf667f2504eb18e1ef92a5af4" class="ppd-card alignfull no-bottom-card has-hex "> <div class="ppd-card__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2023/10/icon-regulatory-publishing-solutions.svg" alt=""> </div> <div class="ppd-card__inner pad-btm"> <div class="ppd-card__top"> <p class="ppd-card__content"><strong>Regulatory Publishing Solutions (RPS)</strong>: Develop submission strategy, provide project planning, tracking, management, prepare and manage source documents, and assemble, publish, and validate submissions.</p> </div> <div class="ppd-card__bottom"> </div> </div> </div> </div></div> <div class="wp-block-emagine-column emagine-column2173 inner-column-2"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="ppd-card-block_fce79d1412978e80d9935c5a2e894c27" class="ppd-card alignfull no-bottom-card has-hex "> <div class="ppd-card__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2023/10/icon-labeling-services.svg" alt=""> </div> <div class="ppd-card__inner pad-btm"> <div class="ppd-card__top"> <p class="ppd-card__content"><strong>Labeling services</strong>: Develop clinical and peri- and post-approval content (development/company core data sheets (DCDS/CCDS), core/company core safety information (DCSI/CCSI), FDA target product profile (TPP), investigational product label/label mock-up), summary of product characteristics (SmPC), United States Prescribing Information (USPI), package information leaflet (PIL), review global advertising/promotional materials, and provide translation services.</p> </div> <div class="ppd-card__bottom"> </div> </div> </div> </div></div> <div class="wp-block-emagine-column emagine-column6027 inner-column-3"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><div id="ppd-card-block_ee258afd534b592ff86fa2a3695a4580" class="ppd-card alignfull no-bottom-card has-hex "> <div class="ppd-card__hexagon"> <img decoding="async" src="https://www.ppd.com/wp-content/uploads/2023/10/icon-project-management-and-oversight.svg" alt=""> </div> <div class="ppd-card__inner pad-btm"> <div class="ppd-card__top"> <p class="ppd-card__content"><strong>Project management and oversight</strong>: Lead and oversee operational teams, merging project management capability with deep regulatory expertise, measure efficiency and quality using robust metrics and KPIs to drive improvements, adapt to changes in the field, manage cross-functional teams and identify, and coordinate consultations with subject matter experts, as needed.</p> </div> <div class="ppd-card__bottom"> </div> </div> </div> </div></div> </div></div></div> <section id="cross-functional" class="media-content alignfull has-bg-image dark-text thirds-layout invert-mobile align-content-center " style=""> <div class="alignwide align-bg"> <div class="media-content__content has-container left-content"> <div class="content-container"> <h2 class="media-content__title2">Cross-functional experts increase the probability of success</h2> <div class="media-content__desc"><p>Creating and executing a regulatory plan that increases the likelihood of product approval requires specialized, customized, cross-functional expertise. To meet your evolving needs and proactively anticipate and overcome challenges, our cross-functional teams include a customized mix of roles. We employ a mix of senior staff members with long-running regulatory experience in the pharmaceutical and medical device industries along with regulatory professionals and chemistry, manufacturing & controls (CMC) specialists.</p> <p>Each team of decision makers is empowered with the flexibility to provide solutions that meet your unique needs. A typical team may include:</p> <ul> <li>A regulatory oversight director accountable for strategic management of the portfolio</li> <li>A regulatory affairs lead as the primary client contact, who is accountable for development and execution of strategies and submissions</li> <li>And multiple other roles, as needed, to fill out the team, including regulatory specialists, regulatory country managers, regulatory assistants, or clinical and commercial roles</li> </ul> <p>By bridging regulatory affairs knowledge with extensive clinical and commercial expertise, our team develops strategies that enable the most efficient registration pathways to maximize the probability of regulatory approval and fair market access.</p> </div> </div> </div> <div class="media-content__image bg-image" style="background-image: url(https://www.ppd.com/wp-content/uploads/2023/10/fsp-regulatory-team-min.jpg);"></div> </div> </section> <div class="wp-block-emagine-columns alignfull align-bg-left"><div id="em-layout-id_cc08c3-d9" class="em-row-layout-inner em-margin-top--none em-margin-bottom--none em-tablet-margin-top--none em-tablet-margin-bottom--default em-mobile-margin-top--none em-mobile-margin-bottom--none em-row-has-bg em-layout-id_cc08c3-d9"><div class="em-row-column-wrap em-has-1-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-inherit em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--none em-padding-bottom--none em-tablet-padding-top--default em-tablet-padding-bottom--default em-mobile-padding-top--default em-mobile-padding-bottom--default alignfull"> <div class="wp-block-emagine-column emagine-column3962 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"><section id="global-reach" class="media-content alignfull has-bg-image dark-text thirds-layout align-content-center " style=""> <div class="alignwide align-bg"> <div class="media-content__image bg-image" style="background-image: url(https://www.ppd.com/wp-content/uploads/2023/10/fsp-regulatory-diverse-global-team-min-e1698076809902.jpg);"></div> <div class="media-content__content has-container right-content"> <div class="content-container"> <h2 class="media-content__title2">Global reach and specialized expertise helps accelerate your outcomes</h2> <div class="media-content__desc"><p>With regulatory staff located throughout North America, Europe, Middle East, Africa, Latin America and Asia-Pacific – including one of the largest and most experienced regulatory teams in China – we deliver the specialized expertise needed to navigate local regulatory requirements, facilitate efficient reviews of applications and accelerate outcomes. We also leverage our regulatory FLEX Solutions Team (an adaptable resource pool in Mexico, India, the Philippines and Bulgaria) to effectively scale to manage changing needs.</p> <p>In addition, we apply our extensive clinical and regulatory experience and expertise – and long-standing trusted relationships with national and regional regulatory authorities – to proactively monitor potential risks and challenges and anticipate and address queries raised.</p> <p>Our global footprint and breadth of regulatory experience also gives us a clear view of the regulatory affairs future. By applying our local, regional and central regulatory intelligence, our active engagement and influence with industry and global health authorities, and regulatory thought leadership across a range of health authorities and stakeholders, we’re able to proactively address current challenges and influence future strategies across multiple geographies, product classes and regulatory agencies.</p> </div> </div> </div> </div> </section> </div></div> </div></div></div> <section id="proven-systems" class="media-content alignfull has-bg-image dark-text thirds-layout invert-mobile align-content-bottom " style=""> <div class="alignwide align-bg"> <div class="media-content__content has-container left-content"> <div class="content-container"> <h2 class="media-content__title2">Proven systems provide the foundation for successful submissions</h2> <div class="media-content__desc"><p>The regulatory landscape is dynamic and continually evolving, driven by local regulatory requirements, medical, scientific and technological advances, as well as industry and political influences. Amid rapid regulatory changes and anticipated significant changes to come, staying up to date with regulatory intelligence is key to a successful regulatory strategy.</p> <p>To stay current on the latest regulatory updates, we continuously share intelligence gathered from our successful regulatory submissions at relevant meetings and forums worldwide. We also incorporate our intelligence and learnings into our systems to enable clients easy access to their data and submission archive and allow multiple parties to securely move seamlessly from one step to the next.</p> <p>In addition, we apply our extensive clinical and regulatory experience and expertise – and long-standing trusted relationships with national and regional regulatory authorities – to proactively monitor potential risks and challenges and anticipate and address queries raised.</p> <p>Our global footprint and breadth of regulatory experience also gives us a clear view of the regulatory affairs future. By applying our local, regional and central regulatory intelligence, our active engagement and influence with industry and global health authorities, and regulatory thought leadership across a range of health authorities and stakeholders, we’re able to proactively address current challenges and influence future strategies across multiple geographies, product classes and regulatory agencies.</p> </div> </div> </div> <div class="media-content__image bg-image" style="background-image: url(https://www.ppd.com/wp-content/uploads/2022/11/drug-product-lifecycle-731640976.jpg);"></div> </div> </section> <div class="wp-block-emagine-columns alignfull"><div id="em-layout-id_c75b0d-c0" class="em-row-layout-inner em-margin-top--none em-margin-bottom--none em-tablet-margin-top--none em-tablet-margin-bottom--none em-mobile-margin-top--none em-mobile-margin-bottom--none em-layout-id_c75b0d-c0"><div class="em-row-column-wrap em-has-1-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-inherit em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--xlarge em-tablet-padding-top--none em-tablet-padding-bottom--default em-mobile-padding-top--small em-mobile-padding-bottom--xlarge alignwide"> <div class="wp-block-emagine-column emagine-column3048 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"> <h3 class="wp-block-heading has-text-align-left" style="text-transform:none">Systems we leverage include:</h3> <div class="wp-block-emagine-columns alignfull"><div id="em-layout-id_368049-7f" class="em-row-layout-inner em-margin-top--small em-margin-bottom--none em-tablet-margin-top--none em-tablet-margin-bottom--none em-mobile-margin-top--small em-mobile-margin-bottom--none em-layout-id_368049-7f"><div class="em-row-column-wrap em-has-3-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-inherit em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--default em-tablet-padding-top--default em-tablet-padding-bottom--default em-mobile-padding-top--default em-mobile-padding-bottom--default alignfull"> <div class="wp-block-emagine-column emagine-column9416 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"> <ul class="wp-block-list"> <li><strong>RegView</strong>: Provides proprietary, actionable regulatory intelligence from around the world through daily updates and is validated with extensive personal experience – including more than 13,000 summaries in over 150 countries for early development through post-approval and over 1,300 cross-country reports are updated daily<strong>.</strong></li> </ul> </div></div> <div class="wp-block-emagine-column emagine-column8008 inner-column-2"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"> <ul class="wp-block-list"> <li><strong>Publishing solution</strong>: Expedites the delivery and validation of submissions, via a “follow the sun” resourcing model, by creating regulatory compliant PDF files and validation tools to ensure quality published outputs satisfy technical requirements for health authority gateways and portals</li> </ul> </div></div> <div class="wp-block-emagine-column emagine-column7789 inner-column-3"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"> <ul class="wp-block-list"> <li><strong>Veeva Vault Regulatory Information Management System (RIMS)</strong>: Supports timely and compliant management of end-to-end regulatory processes, including planning and tracking documents, submissions, registrations, commitments and more</li> </ul> </div></div> </div></div></div> <div class="wp-block-emagine-columns alignfull"><div id="em-layout-id_9694a0-12" class="em-row-layout-inner em-margin-top--default em-margin-bottom--none em-tablet-margin-top--default em-tablet-margin-bottom--none em-mobile-margin-top--default em-mobile-margin-bottom--none em-layout-id_9694a0-12"><div class="em-row-column-wrap em-has-2-columns em-gutter-default em-row-valign-top em-row-layout-left-golden em-tab-layout-left-golden em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--default em-padding-bottom--default em-tablet-padding-top--default em-tablet-padding-bottom--default em-mobile-padding-top--default em-mobile-padding-bottom--default alignfull"> <div class="wp-block-emagine-column emagine-column4604 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"> <p class="has-text-align-left">With these systems, we facilitate extensive intelligence and experience sharing. This improves the quality of decision making, creates efficiencies, increases consistency, accuracy, and reliability, and improves the odds of submission success.</p> </div></div> <div class="wp-block-emagine-column emagine-column9649 inner-column-2 hide-on-mobile"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--none em-mobile-padding-right--none em-mobile-padding-bottom--none em-mobile-padding-left--none"></div></div> </div></div></div> </div></div> </div></div></div> <section id="bg-content-block-block_58a183532abcfe17174c4ff6c8b87444" class="bg-content-block alignfull" style="background-image: url(https://www.ppd.com/wp-content/uploads/2023/10/fsp-regulatory_ss793366144.jpg);"> <div class="bg-content-block__overlay"> <div class="inner alignwide"> <div class="bg-content-block__body"> <h2 class="bg-content-block__title">The clear choice for your FSP regulatory affairs needs</h2> <div class="bg-content-block__content"><p>Whether supporting a critical business task, a clinical trial, an entire portfolio or providing post-approval life cycle management, <a href="/wp-content/uploads/2021/03/PPD-FSP-Services-Overview.pdf">PPD Functional Service Partnership</a> Regulatory Affairs solutions employ a scalable approach. We bring the right resources at the right time with an uncompromising commitment to quality — while providing much-needed resource flexibility, reliability and continuity.</p> <p>Through our comprehensive expertise and insights, customized approach and cutting-edge systems, we help you navigate global regulatory environments.</p> </div> </div> </div> </div> </section> <div class="wp-block-emagine-columns alignfull" id="contact-ppd"><div id="em-layout-id_4720cb-0a" class="em-row-layout-inner em-margin-top--none em-margin-bottom--none em-tablet-margin-top--none em-tablet-margin-bottom--none em-mobile-margin-top--none em-mobile-margin-bottom--none em-row-has-bg em-layout-id_4720cb-0a"><div class="em-row-column-wrap em-has-1-columns em-gutter-default em-row-valign-top em-row-layout-equal em-tab-layout-inherit em-m-colapse-left-to-right em-mobile-layout-row em-padding-top--xlarge em-padding-bottom--xlarge em-tablet-padding-top--xlarge em-tablet-padding-bottom--xlarge em-mobile-padding-top--xlarge em-mobile-padding-bottom--xlarge aligndefault"> <div class="wp-block-emagine-column emagine-column4177 inner-column-1"><div class="em-inside-inner-col em-padding-top--none em-padding-right--none em-padding-bottom--none em-padding-left--none em-tablet-padding-top--none em-tablet-padding-right--none em-tablet-padding-bottom--none em-tablet-padding-left--none em-mobile-padding-top--small em-mobile-padding-right--small em-mobile-padding-bottom--small em-mobile-padding-left--small"> <h3 class="wp-block-heading">Ready to accelerate market access and ensure approval success? 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