AAIPharma’s Regulatory Affairs team offers clients a staff of experts with the knowledge and experience to support your regulatory needs throughout the entire product lifecycle from the Pre-Investigational New Drug Application meetings through marketing application approval to post-approval lifecycle management.  We work in tandem with your team and our formulations, analytical, manufacturing and stability experts to help you design the most efficient product development program and assure a complete regulatory package is provided in compliance with current regulatory standards.

We offer:

  • Strategic Regulatory Planning
  • Pre-submission regulatory application readiness assessment
  • FDA meeting assistance including scientific advice requests, materials, preparation and follow-up
  • Preparation of U.S. Drug Product Applications in electronic Common Technical Document (e-CTD) format; Investigational New Drug applications (IND), New Drug (NDA), Abbreviated New Drug applications (ANDA).
  • Serve as FDA U.S. Agent representative for foreign companies
  • Perform regulatory due diligence
  • Post-approval support (supplements, amendments, annual reports, manufacturing and material change assessments)
  • Common Technical Document (CTD) preparation to support foreign marketing applications

Contact us for more information about our Regulatory Affairs services.