Scientific Regulatory Affairs and Regulatory Documentation

• Global Drug Master File (DMF) Preparation and Maintenance
• Investigational New Drug Application (IND), Amendments, Safety Reporting, and Annual Reports
• New Drug Application (NDA), Amendments, and Supplement Annual Reports, and Postmarketing Reporting
• 505(b)(2) NDA Application, Amendments, Annual Reports, and Postmarketing Reporting
• Abbreviated New Drug Applications (ANDA), Amendments, Safety Reporting, and Annual Reports
• Premarket Notification Application (510(k)) preparation
• Certificate of suitability
• Clinical Trials Application (CTA)
• Investigational Medicinal Product Dossier (IMPD)
• Premarket Approved Application (PMA)
• Investigational Device Exemption (IDE) preparation and maintenance
• Prescription drug and over-the-counter drug labeling preparation
• Orphan Drug Designation Request (ODDR) preparation and maintenance
• Fast Track Requests preparation and maintenance
• Biologics License Application (BLA) preparation and maintenance
• United States Adopted Name (USAN) Application preparation
• Product Registration
• Establishment Registration