Regulatory Affairs

Our Regulatory Affairs team understands the regulatory process and can help you navigate your project to approval and market. The group offers clients a staff of CMC experts having a wide scope of experience. Additionally, the science-based staff has first-hand CMC knowledge and experience in formulations development, analytical method development/validation and testing, pharmaceutical manufacturing, stability study design and project management. We work in tandem with your team and AAIPharma’s formulations, analytical, manufacturing and stability experts to assure the best possible presentation of CMC materials to worldwide regulatory authorities.

We offer:

Preparation of IND, NDA, ANDA and CTA submissions
CMC submission writing, organization, assembly, quality review and filing
Meeting assistance including scientific advice requests, materials, preparation and follow-up
Liaison activities to global regulatory authorities
CMC submission critique and assessment
Agent representation to FDA and European agencies
Dedicated RA professional to work closely with you to meet your submission needs
Post-approval support (supplements, amendments, annual reports, manufacturing and material change assessments)