Working with the FDA
For firms with limited experience dealing with the US Food and Drug Administration, Reguliance can assist in detailing the expectations of the FDA, its structure and operating logistics. We have hands-on practical experience working with the FDA, and together with our knowledge of their regulations and guidances, we can assist you in determining what regulations and requirements apply to your specific development project.
Meeting with the FDA
With your development proposals in place, it is now time to meet with the FDA. Reguliance can help you plan and prepare for your FDA meetings. Whether it is your first FDA meeting, a mid-development meeting, or an end of development meeting, we can help you with both document preparation and meeting logistics. We can assist you in arranging and preparing for a variety of meetings, including:
- Pre-IND meetings
- End of Phase I/ II (EOP I or II) meetings
- Pre-NDA, Pre-BLA, or Pre-ANDA meetings
- Post-approval meetings
- Compliance meetings
Submissions to the FDA
Reguliance can assist you in preparing, reviewing, and submitting FDA required documentation including:
- Orphan Drug Designation Requests
- Investigational New Drug Applications (IND)
- Drug Master Files (DMFs) and Biologics Master Files (MFs)
- New Drug Applications (NDAs)
- Abbreviated New Drug Applications (ANDAs)
- Biologics License Applications (BLAs)
- Establishment Registration and Product Listing
- Generic Facility Self-ID
- Generic Drug Controlled Correspondence
- ANDA Suitability Petitions