Foreign firms are required by regulation to use a registered US Agent for many interactions with the FDA. Reguliance has extensive experience in providing US Agent representation to small- and medium-size foreign companies.
As your appointed US Agent, Reguliance is the primary contact in all dealings with the FDA. Reguliance will work with your organization to:
- Prepare and submit Orphan Drug Designation applications
- Prepare and submit Drug Master File (DMF) or Biologic Master File (MF) applications (a US Agent is not required but recommended by the FDA)
- Prepare and submit Investigational New Drug (IND) applications
- Prepare and submit generic drug Controlled Correspondence
- Prepare and facilitate communications and meetings (Pre-IND, End-of-Phase I/II, Pre-NDA/BLA and Pre-ANDA) with the FDA to discuss your drug development
- Prepare and submit Establishment Registrations and Drug Listing and Generic facility Self-Identification
- Interpret FDA acts, regulations, and guidance documents to prepare development strategy