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Regulatory

Our Regulatory Affairs team plays a pivotal role in your project from its initiation to its completion, ensuring compliance with all applicable laws and regulations throughout the process. We assist with clinical trial applications, maintenance and regulatory trial support. Our services are included in the full-service clinical study programs, but are also provided as a standalone service. All documents are accurately reviewed to ensure they are compliant with regulatory requirements.

Our regulatory affairs services include:

Pfeil Review of study documents (protocol, patient information sheets/informed consent forms, drug labels, etc.) to ensure they have been prepared according to regulatory requirements
Pfeil Regulatory support for clinical studies concerning drugs, medical devices or food: compilation of clinical trial application dossiers, request of clinical trial authorization from competent authorities, obtaining favorable opinions of ethics committees, notifications to authorities
Pfeil Support for clinical studies concerning pharmacovigilance, including electronic reporting to EudraVigilance
Pfeil Consulting on regulatory questions
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Contact
FGK Clinical Research GmbH
Heimeranstrasse 35
80339 Munich
Germany
T | +49 (0) 89 893 119-0
F | +49 (0) 89 893 119-20
www.fgk-cro.com
info@fgk-cro.com