Regulatory and Medical Affairs in Clinical Trials

 

Representation of non-EU sponsors in front of EU Health authorities
Preparation and submission of CTA, Protocol amendments, End-of-study notification, Clinical Study Report
Consultancy and expertise on regulatory and legal requirements
Liaision with regulatory and Ethics authorities
Regulatory guidance at all stages of product development
Interactions with regulatory authorities to coordinate FDA and EMEA inspection activities
Maintenance and archiving of clinical regulatory documents
Support of product labeling activities
Import licences support for Investigational Product
Annual Safety Reports submission
SUSARs and CIOMS submissions