Scientific Regulatory Affairs and Regulatory Documentation


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  • 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