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id="text-box-1242482172" class="text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text"> <div data-animate="fadeInDown"> <div class="text-box-content text dark text-shadow-2"> <div class="text-inner text-center"> <div id="text-785205323" class="text"> <h1 class="uppercase">Pharma</h1> <style> #text-785205323 { text-align: left; } </style> </div> </div> </div> </div> <style> #text-box-1242482172 { width: 84%; } #text-box-1242482172 .text-box-content { font-size: 111%; } @media (min-width:550px) { #text-box-1242482172 { width: 100%; } #text-box-1242482172 .text-box-content { font-size: 100%; } } </style> </div> </div> </div> <style> #banner-1039415652 { padding-top: 600px; } </style> </div> <section class="section has-parallax" id="section_1052187261"> <div class="section-bg fill" data-parallax-container=".section" data-parallax-background data-parallax="-3"> <img decoding="async" width="1600" height="1000" src="https://toxhub-consulting.com/wp-content/uploads/2024/09/b2.jpg" class="bg attachment-original size-original" alt=""> </div> <div class="section-content relative"> <div id="gap-1819310810" class="gap-element clearfix" style="display:block; height:auto;"> <style> #gap-1819310810 { padding-top: 50px; } </style> </div> <div class="row" id="row-87673441"> <div id="col-328623648" class="col small-12 large-12"> <div class="col-inner"> <p class="alt-font uppercase" style="text-align: center;"><span style="color: #142441; font-size: 38px;">Tailored advisory for Pharmaceuticals</span></p> <p class="alt-font" style="text-align: center;">Ensuring compliance and optimizing toxicology<br>In the highly regulated pharmaceutical sector, strict compliance with laws and guidelines is crucial for success. Navigating EU regulations and directives, along with complex agency guidance, is essential to avoid serious consequences.</p> <p class="alt-font" style="text-align: center;">From optimizing drug development and manufacturing processes to ensuring compliance with global standards, our dedicated team supports every stage—from development to post-market product safety.</p> </div> </div> </div> <div class="row row-box-shadow-2" id="row-1252457774"> <div id="col-1350146805" class="col small-12 large-12"> <div class="col-inner"> <h3>Non-Clinical Services:</h3> <p><span data-contrast="auto">At ToxHub, we offer a broad range of non-clinical services to support pharmaceutical development:</span><span data-ccp-props='{"134233117":true,"134233118":true,"201341983":0,"335551550":6,"335551620":6,"335559740":240}'> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"> <b><span data-contrast="auto">De-risking of drug candidates</span></b><span data-contrast="auto"> during early discovery phases through custom-made toxicology strategies, including design, timelines, and evaluation of results for </span><b><span data-contrast="auto">in silico (QSAR), in vitro, and in vivo</span></b><span data-contrast="auto"> investigational non-GLP studies.</span><span data-ccp-props='{"134233117":true,"201341983":0,"335551550":6,"335551620":6,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="2" data-aria-level="1"> <b><span data-contrast="auto">Toxicity and Safety Pharmacology</span></b><span data-contrast="auto"> study identification, protocol design, laboratory proposal management, and assistance with laboratory selection, including site visits.</span><span data-ccp-props='{"134233117":true,"201341983":0,"335551550":6,"335551620":6,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="3" data-aria-level="1"> <b><span data-contrast="auto">On-site study monitoring, data interpretation</span></b><span data-contrast="auto">, and </span><b><span data-contrast="auto">study report reviews</span></b><span data-contrast="auto"> for both GLP and non-GLP studies.</span><span data-ccp-props='{"134233117":true,"201341983":0,"335551550":6,"335551620":6,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="4" data-aria-level="1"> <b><span data-contrast="auto">Investigation of Mode of Action</span></b><span data-contrast="auto"> and human relevance concerning toxicological effects.</span><span data-ccp-props='{"134233117":true,"201341983":0,"335551550":6,"335551620":6,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="5" data-aria-level="1"> <span data-contrast="auto">Non-clinical services for </span><b><span data-contrast="auto">Paediatric Investigation Plans (PIP)</span></b><span data-contrast="auto"> according to European Regulation (EC) No 1901/2006, including juvenile study protocol design and excipient analysis for specific paediatric formulations.</span><span data-ccp-props='{"134233117":true,"201341983":0,"335551550":6,"335551620":6,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="6" data-aria-level="1"> <b><span data-contrast="auto">Non-clinical local tolerance evaluations</span></b><span data-contrast="auto"> to support human exposure to drug products (active substances and excipients) at contact sites, following the EMA Guideline (EMA/CHMP/SWP/2145/2000 Rev. 1).</span><span data-ccp-props='{"134233117":true,"201341983":0,"335551550":6,"335551620":6,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> </div> </div> <div id="col-223715449" class="col small-12 large-12"> <div class="col-inner"> <h3>Pharma Risk Assessment Services</h3> <p><span data-contrast="auto">At ToxHub, we provide specialized risk assessment services to ensure the safety and compliance of your pharmaceutical products:</span><span data-ccp-props='{"134233117":true,"134233118":true,"201341983":0,"335559740":240}'> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"> <b><span data-contrast="auto">Excipient safety assessment</span></b><span data-contrast="auto">, including exposure scenarios, Margin of Safety (MoS) calculations, including proposal for adjusting administration dosages, and evaluation of site-of-contact reactions.</span><span data-ccp-props="{}"> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="2" data-aria-level="1"> <b><span data-contrast="auto">Risk assessment and qualification strategies</span></b><span data-contrast="auto"> for process impurities and other contaminants, such as </span><b><span data-contrast="auto">Nitrosamines</span></b><span data-contrast="auto">.</span><span data-ccp-props='{"134233117":true,"201341983":0,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="3" data-aria-level="1"> <b><span data-contrast="auto">Extractables & Leachables (E&L) risk assessment</span></b><span data-contrast="auto">, ensuring product safety and regulatory compliance.</span><span data-ccp-props='{"134233117":true,"201341983":0,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="4" data-aria-level="1"> <b><span data-contrast="auto">In silico assessment</span></b><span data-contrast="auto"> (QSAR modelling, analogue identifications and read across justification) of toxicological endpoints for data-poor substances, as per ICHM7.</span><span data-ccp-props='{"134233117":true,"134233118":true,"134233279":false,"201341983":0,"335551550":6,"335551620":6,"335559740":240}'> </span> </li> </ul> </div> </div> <div id="col-1011402727" class="col small-12 large-12"> <div class="col-inner"> <h3>PDE and OEL Services</h3> <p><span data-contrast="auto">At ToxHub, we offer expert services for the derivation of safety exposure limits:</span><span data-ccp-props='{"134233117":true,"134233118":true,"201341983":0,"335559740":240}'> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="5" data-aria-level="1"> <b><span data-contrast="auto">Permissible Daily Exposure (PDE)</span></b><span data-contrast="auto"> levels to address cross-contamination in shared facilities for active pharmaceutical ingredients (API) and isolated pharmaceutical intermediates (IPI).</span><span data-ccp-props='{"134233279":false,"335559685":714,"335559739":120,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="6" data-aria-level="1"> <b><span data-contrast="auto">Occupational Exposure Limits (OEL/OEB)</span></b><span data-contrast="auto"> for active pharmaceutical ingredients (API) and isolated pharmaceutical intermediates (IPI) in the work environment.</span><span data-ccp-props='{"134233279":false,"335559685":714,"335559739":120,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="7" data-aria-level="1"> <b><span data-contrast="auto">PDE and OEL</span></b><span data-contrast="auto"> assessments for shared facilities of </span><span data-contrast="auto">veterinary products, </span><span data-contrast="auto">according to VICH GL18.</span><span data-ccp-props='{"134233279":false,"335559685":714,"335559739":120,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}' aria-setsize="-1" data-aria-posinset="8" data-aria-level="1"> <span data-contrast="auto">Application of </span><b><span data-contrast="auto">Read-Across and Grouping approaches</span></b><span data-contrast="auto"> for data-poor chemicals for the purpose of filling the data gaps, in accordance with EHCA guidelines.</span><span data-ccp-props="{}"> </span> </li> </ul> <p><span data-ccp-props='{"134233279":false,"335559685":714,"335559739":120}'> </span></p> </div> </div> <div id="col-349549017" class="col small-12 large-12"> <div class="col-inner"> <h3>Environmental Risk Assessment (ERA)</h3> <p><span data-contrast="none">At ToxHub, we conduct </span><b><span data-contrast="none">Environmental Risk Assessments</span></b><span data-contrast="none"> (ERA) for human medicine in compliance with the latest EMA guidance (EMEA/CHMP/SWP/4447/00 Rev. 1 – Corr.), and for </span><b><span data-contrast="none">veterinary medicines, </span></b><span data-contrast="none">according to VICH GL6 e VICH GL38</span><span data-contrast="none">. This includes:</span><span data-ccp-props='{"134233117":true,"134233118":true,"201341983":0,"335551550":6,"335551620":6,"335559740":240}'> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}' aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"> <span data-contrast="auto">Comprehensive literature search using public and commercial databases;</span><span data-ccp-props='{"134233117":true,"201341983":0,"335551550":6,"335551620":6,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}' aria-setsize="-1" data-aria-posinset="2" data-aria-level="1"> <span data-contrast="auto">Estimation of environmental exposure; Persistence, Bioaccumulation and Toxicity (PBT); calculation of the initial Predicted Exposure Concentration (PEC);</span><span data-ccp-props='{"134233117":true,"201341983":0,"335551550":6,"335551620":6,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}' aria-setsize="-1" data-aria-posinset="3" data-aria-level="1"> <span data-contrast="none">Evaluation and Testing Strategy for Endocrine Disruptors (ED);</span><span data-ccp-props='{"134233279":false,"201341983":0,"335559685":714,"335559739":120,"335559740":240,"335559991":357}'> </span> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props='{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}' aria-setsize="-1" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Application of Read-Across and Grouping approaches for data-poor chemicals for the purpose of filling the data gaps, in accordance with EHCA guidelines.</span></li> </ul> </div> </div> <style> #row-1252457774 > .col > .col-inner { padding: 25px 30px 25px 30px; 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