Our services

Regulatory Affairs Consulting

Abbreviated New Drug Application(ANDA)

Administrative

  • Form FDA-356h Review
  • Form FDA-3794: GDUFA Cover Sheet Form Review
  • FDA-3674: Certification of Compliance Review
  • Table of Content Review
  • Certifications Review
  • Environmental Impact Analysis Review

 eCTD Summaries

  • Quality Overall Summary (QOS) (Drug Substance and Drug Product)
  • Clinical Summary – (In vitro Binding Studies, Clinical and PD Endpoints, Biopharmaceutics Classification System)

Quality

  • Chemistry Manufacturing and Controls Review
  • Drug Product Review

Clinical Studies Report

  • BA/BE Content Review

Our brands and projects