Leverage Expertise in Global Compliance, Expedite Regulatory Filing and Reviews, Prepare Documents Efficiently

GRAM assists clients with clinical trial applications (IND/CTA), new drug submissions (NDA/BLA/ANDA), and supplements (PAS, Type I/II). We can provide documentation in electronic common technical document (eCTD) format to expedite regulatory filings and reviews. GRAM’s regulatory services include:

  • Facilitating regulatory strategy
  • Facilitating interaction with regulatory authorities
  • Approval on drug master files
  • Guidance on regulatory submissions
  • Preparing regulatory documents
  • Specializing in international regulatory guidelines (FDA, EU, TGA and Health Canada)