Our regulatory affairs consultants assist clients with strategy, writing submissions, technical documentation, remediation, and resolution management for:
- Investigational Device Exemptions (IDEs)
- 510(k) submissions
- Premarket Approvals (PMAs)
- Investigational New Drug (IND) applications
- Chemistry, Manufacturing & Controls (CMC) submissions
- New Drug Applications (NDAs)
- Biological License Applications (BLAs)
- Adverse Event Reports (AERs)
- Technical files
- Design dossiers
- . . . and more
Our regulatory affairs consultants deliver expert guidance to clients throughout Europe and the U.S. for the pharmaceutical, medical device, and biotechnology industries.
Let Oxford Life Sciences help you with your regulatory affairs recruiting and consulting needs.