Regulatory Affairs Services

Regulatory affairs services are provided in accordance with FDA regulations 21 CFR 50, 54, 56, 58, 200, 211, 312, 314, 600, 800, and include, but are not limited to:

• Review, prepare, and publish FDA submissions, to include original Investigational New Drug (IND) Applications and amendments, Biologics License Application (BLA) and New Drug Application (NDA) and supplements, Master Files (MF), annual reports, requests for Orphan Drug and Breakthrough Therapy Designations, Accelerated Approval, Fast Track, and Priority Review.

• FDA meeting preparation, to include preparation of technical documentation, meeting requests, and briefing packages; liaison with FDA, management, and rehearsals.

• Conduct Immunogenicity Risk Assessments for inclusion in submissions and presentation to regulatory authorities.

Regulatory affairs services also include providing guidance on all aspects of regulatory strategy for product development and conduct of due diligence.