We can help you put together a regulatory strategy document to determine your pathway forward. Plans can be validated by preparing briefing documents and support through Regulatory Agency meetings both in Europe (nationally and with EMA) and in the US. We can manage your development program from the very early stages of development through to submission.
Our Regulatory Affairs services include:
- Regulatory Strategy
- Notification to Competent Authorities
- EUDRACT Study Number
- Submission and correspondence with Ethics Committees
- Statistical Analysis and/or Medical Writing for Integrated Summaries of Efficacy (ISE) and Integrated Summaries of Safety (ISS)
- Support with the Small Medium Enterprise (SME) office of the EMA