US Regulatory Affairs

WR can assist in detailing the expectations of the FDA, its structure, and operating logistics. With extensive knowledge in FDA regulation and guidance, WR can help determine what regulations and requirements apply to a specific development project and help tackle the regulatory challenges that arise.

Meeting with the FDA

  • Pre-IND meetings

  • End of Phase I/ II (EOP I or II) meetings

  • Pre-NDA, Pre-BLA, or Pre-ANDA meetings

  • Type C Meetings

Submissions to the FDA

  • 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

  • Rare Pediatric Disease Designations Requests

  • Qualified Infectious Disease Product Designations

Regulatory Affairs Strategy

  • Assist in the US regulatory definition of the product (drug/biologic/device/combination product)

  • Assist in defining the regulatory pathway (IND/NDA/BLA/ANDA/Device)

  • Assist in GAP analysis of the regulatory activities

  • Interpret US legislation, FDA regulations, and guidance documents to prepare development strategy