Regulatory Affairs and Consulting

Medicinal product development requires input and approval from regulatory authorities (e.g. FDA, EMA) from early clinical phases up to market authorization and thereafter. During the different phases of drug development, critical issues may arise that need input from regulatory authorities. Practical regulatory affairs issues need to be considered, such as when is the best time in the development process to consult regulatory authorities, how to formulate questions to get the answer you need and how to get approval from the regulatory agencies for the proposed drug development program. Venn’s regulatory affairs consultants can help with all the regulatory aspects of the drug development process from pre-clinical to post authorisation. Our experienced regulatory consulting team guides sponsors through the regulatory process and provides the required submission documents at any stage of development.

Our services include

• Strategic and Regulatory Consulting
• Communication with regulatory authorities
• Preparation of country specific submission documents / medical writing
• Clinical Trial Applications
• CMC regulatory affairs
• Non-clinical regulatory documentation
• Medical writing
• Pharmacovigilance and QPPV
• Marketing authorization support for sponsors outside EU
  • Conduct of Post-Authorization Safety Studies (PASS), non-interventional/observational studies, registry studies
  • Interaction with regulatory agencies world-wide
  • Preparation of end-of-trial declarations
  • Preparation & submission of medical device trials

How can we help ? Contact David Collins for more information – david.collins@vennlife.com