--- title: Profil的临床法规事务团队 description: Profil强大的临床法规事务团队是在法规审查和临床试验授权中取得成功的关键要素。 --- [![profil-logo-wortbild-with claim-4c-offset_1000px-1](https://www.profil.com/hs-fs/hubfs/profil-logo-wortbild-with%20claim-4c-offset_1000px-1.png?width=1000&name=profil-logo-wortbild-with%20claim-4c-offset_1000px-1.png "profil-logo-wortbild-with claim-4c-offset_1000px-1")](https://www.profil.com?hsLang=zh) [![Contact](https://no-cache.hubspot.com/cta/default/481167/1f89c7d1-107f-4c8d-aa7b-f85d0dce14da.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/1f89c7d1-107f-4c8d-aa7b-f85d0dce14da) [Patient information](https://www.profil.de) # [![Header_1077x260px_FurtherServices-1](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/Header/Header_1077x260px_FurtherServices-1.jpg?width=1077&height=260&name=Header_1077x260px_FurtherServices-1.jpg) 监管处理 Profil的监管事务团队](https://www.profil.com/zh/services/regulatory-handling#) ## 成功的临床试验授权关键 Profil在指导我们的合作伙伴成功进行临床试验监管提交方面具有丰富的专业知识。面对相关机构，例如联邦药品和医疗器械研究所（BfArM）及德国道德委员会（ECs），我们拥有15年的处理经验，并且清楚知道如何最大程度地减少甚至完全避免审批过程中的延误。 我们的临床监管事务团队成员均拥有药物监管事务硕士学位，并且在药品和医疗器械提交方面拥有多年经验。在监管提交之前，他们会对所有的提交包进行彻底检查并且帮助解决关键问题。 自临床试验指令2001/20/EC实施以来，Profil已向BfArM和/或德国道德委员会提交了350多项试验。这一数字包括了多项根据2010年欧洲指令93/42 / EEC医疗器械试验的成功监管提交。   **事实与数据** - 进行临床试验申请备案的经验，包括协助准备试验用药品文件（IMPD） - 根据德国医疗器械法（MPG）进行医疗器械试验提交的经验 - 向欧盟委员会和主管当局提交所有必要文件 - 协助答复道德委员会和主管部门的不合格意见书 - 使用特定数据库跟踪所有相关时间表 **我们的临床开发咨询团队与监管专家携手合作，设计并准备监管文件。** **了解更多有关****[临床开发咨询活动的信息](https://www.profil.com/services/clinical-development-consulting?hsLang=zh)****。** ![pikto2.png](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_NewWebinar.png?width=62&height=70&name=Icon_NewWebinar.png) ### 免费咨询 您正在计划一项研究？ 请确保现在就申请免费的项目咨询。 [![立即申请](https://no-cache.hubspot.com/cta/default/481167/eb367922-972d-4e85-9106-62af5243f0a4.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/eb367922-972d-4e85-9106-62af5243f0a4) ![Elke_Hexagon](https://www.profil.com/hs-fs/hubfs/Mitarbeiter/Elke_Hexagon.png?width=154&height=175&name=Elke_Hexagon.png) ### 我们的专家 **Elke Gurschke** 高级法规事务经理 [![与她联系](https://no-cache.hubspot.com/cta/default/481167/5923e04d-af60-4016-8ea9-a353fb5d5ca3.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/5923e04d-af60-4016-8ea9-a353fb5d5ca3) ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_References.png?width=49&height=49&name=Icon_References.png) #### References We have published with the following sponsors: ![Referenzen](https://www.profil.com/hubfs/BLUE_MOON/content-bilder/Referenzen.gif "Referenzen") [View more](https://www.profil.com/knowledge-center/references?hsLang=zh) ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Certificates.png?width=44&height=49&name=Icon_Certificates.png) #### Certificates | ![13485_Zertifikatssiegel_black_A3](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_134852016_certificate_blue.png) ISO 13485:2016 ![27001_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_27001_certificate_.png) ISO 27001 | ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_9001-2015_certificate.png) ISO 9001:2015 ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/BVMA_Logo_Certificate_size.png) BVMA Member | | --- | --- | ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Publications.png?width=44&height=49&name=Icon_Publications.png) #### Publications Marquard J. et al., 2015. Characterization of pancreatic NMDA receptors as possible drug targets for diabetes treatment. Nature Medicine 21, 363–372 (2015). [View all](https://www.profil.com/knowledge-center/publications?hsLang=zh) Profil’s dedicated clinical regulatory affairs team of MDRAs understand clinical trial legal requirements, drug approval laws and the requirements of competent authorities such as the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte; BfArM) and the German Ethics Committees (ECs). We offer **GMP services** and support our partners in minimizing or completely avoiding delays in clinical trial authorization. ###### Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9 · 41460 - Neuss, Germany Telefon +49-2131-4018-345 · marketing@profil.com [Imprint](https://www.profil.com/imprint?hsLang=zh) | [Privacy Policy](https://www.profil.com/privacy?hsLang=zh)