글로벌 규제 서비스 | 써모 피셔 사이언티픽 파테온 (Patheon)

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--hover-color:#E71316;"></i> <i class="fak fa-globalbrand-settings icon fa-stack-1x" style="--color:#E71316;"></i> </span> <div class="largeIconButtonText"> <div class="largeIconButtonTitle">위탁생산</div> <div class="largeIconButtonDesc">제약 산업의 표준이 되는 당사의 고품질 생산 서비스를 확인하세요.</div> </div> </div> </a> </div> <div class="large_icon_button_wrapper"> <a class="large_icon_button_link" href="https://www.patheon.kr/innovative-solutions/supply-chain" data-linkposition="topNavL2"> <div class="large_icon_button_inner"> <span class="fa-stack fa-2x"> <i class="fa fa-circle fa-stack-2x icon-background" style="--color:#3BAD2F10; --hover-color:#3BAD2F;"></i> <i class="fak fa-globalbrand-link icon fa-stack-1x" style="--color:#3BAD2F;"></i> </span> <div class="largeIconButtonText"> <div class="largeIconButtonTitle">공급망 서비스</div> <div class="largeIconButtonDesc">공급망 위험을 완화하기 위한 사전 예방 공급망 전략으로 신뢰를 구축합니다.</div> </div> </div> </a> </div> </div> </div> </div> <div class="navL1 "> <a href="https://www.patheon.kr/our-capabilities" class="l1Text" data-linkposition="topNavL1"> 서비스 <i class="ms-1 fa-solid fa-chevron-down"></i> </a> <div class="l1Menu py-4"> <div class="container-fluid container-lg l1SubMenu d-flex justify-content-evenly align-items-top"> <div class="navIconMenu"> <a href="https://www.patheon.kr/our-capabilities/small-molecule" class="fa-stack fa-2x mb-2"> <i class="fa fa-circle fa-stack-2x icon-background" style="--color:#7474C110; 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--hover-color:#ED7700;"></i> <i class="fak fa-patheon-insights-and-resources icon fa-stack-1x" style="--color:#ED7700;"></i> </span> <div class="largeIconButtonText"> <div class="largeIconButtonTitle">라이브러리</div> <div class="largeIconButtonDesc">당사 전문가가 전하는 마켓 인사이트와 새로운 발견 및 서비스를 확인하세요.</div> </div> </div> </a> </div> <div class="large_icon_button_wrapper"> <a class="large_icon_button_link" href="https://www.patheon.kr/insights-resources/events" data-linkposition="topNavL2"> <div class="large_icon_button_inner"> <span class="fa-stack fa-2x"> <i class="fa fa-circle fa-stack-2x icon-background" style="--color:#26226210; --hover-color:#262262;"></i> <i class="fak fa-patheon-events icon fa-stack-1x" style="--color:#262262;"></i> </span> <div class="largeIconButtonText"> <div class="largeIconButtonTitle">이벤트</div> <div class="largeIconButtonDesc">국내외 이벤트 소식을 확인하고 당사 전문가와 1:1 미팅을 신청하세요.</div> </div> </div> </a> </div> <div class="large_icon_button_wrapper"> <a class="large_icon_button_link" href="https://www.patheon.kr/insights-resources/meet-the-experts" data-linkposition="topNavL2"> <div class="large_icon_button_inner"> <span class="fa-stack fa-2x"> <i class="fa fa-circle fa-stack-2x icon-background" style="--color:#3BAD2F10; 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}); </script> </div> <div class="custom-html-cmp aem-GridColumn aem-GridColumn--default--12"> <style> p{ word-break:keep-all; } </style> </div> </div> </div> </header> <div class="responsivegrid aem-GridColumn aem-GridColumn--default--12"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="cmp-hero aem-GridColumn aem-GridColumn--default--12"> <div id="hero" class="pb-5 pt-5 hero-no-hr "> <div class="container-fluid container-lg"> <h1 class="h1 d-inline-block " style="color:;">글로벌 규제 지원 서비스 </h1> <h2 class="h2 d-block" style="color:;"> 약물 CMC 전략 및 결과물을 위한 최고의 규제 파트너 서비스 </h2> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> </div> </div> </div> <style type="text/css"> .cmp-hero #hero h1 span::before { background-color: ; } #hero { min-height: 500px; } </style> <style type="text/css"> #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: left center; } </style> <style type="text/css"> @media (min-width: 576px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> <style type="text/css"> @media (min-width: 768px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> <style type="text/css"> @media (min-width: 992px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> <style type="text/css"> @media (min-width: 1200px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> <style type="text/css"> @media (min-width: 1400px) { #hero { background-image: url('/content/dam/patheon/global/hero-images/regulatory_expertise_hero_v2.jpg'); background-position: center center; } } </style> </div> <div class="cmp-well aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div class="well " style="background-position-x: center;background-position-y: center;" id="well-386719958"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-171931292"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div id="text-3c56420163" class="cmp-text list-style-bullets"> <p>써모 피셔 사이언티픽은 전 세계 생산시설 네트워크에 규제, 기술, 품질, QP 및 고객 전담 팀을 두고 있으며 이를 기반으로 약물 개발의 모든 단계에서 복잡한 개발 문제를 지원합니다.</p> <p class="p-claim">2013년부터 2022년까지 당사는 가장 많은 NDA/BLA 승인을 받았으며, 이는 차순위 두개 CMO에서 승인받은 수를 합한 것보다 더 많습니다. 입증된 실적과 과학적 전문성은 다수의 글로벌 상위 제약사들이 당사와 파트너를 맺고 있는 주된 이유입니다.</p> <p>당사는 오랜 경험과 다양한 지원 사례를 바탕으로 주요 규제기관(ICH/EMA/FDA)의 가이드라인에 대한 폭넓은 지식을 보유하고 있으며 새로운 규제 동향을 신속하게 파악하기 위해 노력합니다. 당사의 전문적인 규제 지원 서비스는 다수의 고객으로부터 탁월성을 인정받은 바 있습니다.</p> </div> </div> <div class="cmp-well aem-GridColumn aem-GridColumn--default--12"> <div class="well " id="well-819534965"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> </div> </div> </div> <style type="text/css"> #well-819534965 { border-radius: 0px; } </style> </div> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn aem-GridColumn--default--12"> <div id="text-0f93e88f81" class="cmp-text list-style-bullets"> <h2><b>인허가 전략, 승인 관리 전문성 </b></h2> </div> </div> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-f029c23bde" class="cmp-text list-style-check"> <p>당사의 규제 전문팀은 약물의 개발부터 임상, 상업화에 이르는 모든 단계에서 고분자/저분자 약물을 개발하는 고객에게 업계 최고의 허가 지침을 제공합니다. 현재까지 약 150개국에서 인허가 제출을 지원한 바 있습니다.</p> <p>규제 대응 서비스 범위</p> <ul> <li>규제 전략에 대한 신뢰할 수 있는 가이드 제공</li> <li>다음을 포함한 의약품 수명 주기의 모든 단계에서 규제 안내:<ul> <li>신약 허가 신청: IND, IMPD 서류 준비</li> <li>시판 전 허가 신청: 바이오의약품 허가 신청서(BLA) 및 판매허가 신청서(MAA) 준비</li> <li>시판 후 조사: 승인 후 보완 자료(PAS) 및 변형 자료 준비</li> </ul> </li> </ul> <p>복잡한 규제 환경에 철저히 대응하는 것은 약물의 수명주기를 성공으로 인도하는 데 필수적입니다. 전 세계 규제 기간을 대응한 경험과 약물 개발, 스케일업, 기술 이전 팀과의 긴밀한 협업을 통해 고객의 약물을 더 빠르게 출시할 수 있도록 지원합니다.</p> </div> </div> </div> </div> <style type="text/css"> #container-171931292{ background-image: url(''); 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Thermo Fisher Scientific은 여러 가지 유연한 규제 솔루션을 통해...</p> </span> <a href="https://www.patheon.kr/insights-resources/fact-sheets/menu-for-global-regulatory-services-backed-by-industry-experts" target="_self" class="btn library-card-btn library-card-primary-btn "> 더 보기 </a> </div> </div> </div> </div> </div> <style type="text/css"> #container-351904893{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-351904893 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--medium--newline aem-GridColumn--xsmall--newline aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner me-3 " id="container-1115834096"> <div class="aem-Grid aem-Grid--3 aem-Grid--default--3 aem-Grid--xsmall--3 aem-Grid--medium--3 "> <div class="cmp-library-card aem-GridColumn--medium--3 aem-GridColumn--default--none aem-GridColumn--xsmall--3 aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div class="library-card imgType-top" id="library_card-2144253871"> <div class="img-and-tag"> <img class="library-card-top-img" src="/content/dam/temp_patheon/library/thumbnails/oral-solid-dose/Oral_solid_doseH.png" alt=""/> <div class="upper-right-tag"> <i class="fak fa-patheon-brochure pad-right icon"></i> Brochure </div> </div> <div class="library-card-body"> <p class="library-card-preheader"> Brochure </p> <p class="library-card-title"> 약물의 수명주기에 대한 CMC 및 규제 로드맵 개발하기 </p> <span class="library-card-desc"> <p>약물 개발을 시작할 때부터 제대로 된 전략을 수립하는 것이 각 개발 단계를 거쳐 상업화 단계로 진행되는 동안 시간 및 비용 절감에 도움이 됩니다…</p> </span> <a href="https://www.patheon.kr/insights-resources/brochures/developing-a-cmc-and-regulatory-roadmap-for-your-molecules-lifecycle" target="_self" class="btn library-card-btn library-card-primary-btn "> 더 보기 </a> </div> </div> </div> </div> </div> <style type="text/css"> #container-1115834096{ background-image: url(''); 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글로벌 규제 서비스 | 써모 피셔 사이언티픽 파테온 (Patheon) - 써모 피셔 사이언티픽 파테온 (Patheon)