US Agent Services

With extensive experience in providing US Agent representation on behalf of foreign companies and with in-depth understanding of our clients’ markets, WR is the go-to agent for supporting any engagement with the FDA.

As the appointed US Agent, WR will work with clients 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