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 and preparation of 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, and requests for market clearance of medical devices [510(k)s], requests for Orphan Drug Designations, Fast Track, and Priority Review
  • FDA meeting preparation, to include preparation of technical documentation, meeting requests, and background documents; liaison with FDA, management, and rehearsals
  • Conduct Immunogenicity Risk Assessments for inclusion in submissions and presentation to regulatory authorities
  • Design post-marketing pharmacovigilance and REMS (Risk Evaluation and Mitigation Strategies)
  • Drafting of regulatory affairs organization Standard Operating Procedures (SOPs)