We make timely & effective regulatory submissions & filings, address regulatory questions, and negotiate with regulators.
For more information, see our latest Alerts.
Representative matters:
- Regulatory opinions
- Product approval pathway assessments
- 510(k)
- Emergency Use Authorization (EUA)
- Premarket Approval (PMA)
- Pre-IDE
- De novo
- Humanitarian Device Exemptions (HDE)
- Combination Product
- IND
- Pre-IND
- ANDA
- Orphan Drug
- 505(b)(2)
- Pre-Submission meetings
- Panel meetings
- Negotiating clinical trials
- Negotiating labeling
- Modifications
- CE Marking
- CER filing
- Appeals and Citizen Petitions
- Requests for Designation
- FDA meetings
