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
Oxford fills the majority of the regulatory affairs projects for which we compete, with consultants on engagements throughout the U.S. and Europe.
Let Oxford Life Sciences help you with your regulatory affairs recruiting and consulting needs.