We specialize in helping companies create regulatory strategies and submissions, we have global experience in Medical Devices, Pharmaceutical Products, and Combination
Products. Some of the deliverables we can help you with are as follows:
- Creation of regulatory strategy
- Pre-submission meetings with FDA
- CE Mark
- NDA, BLA, and ANDA Submissions
- 510(k) Submissions
- Premarket Approval (PMA)
- Clinical trial submissions (IDE, IND)