You are here Home R & D Astron Research Int’l Regulatory Affairs
Int’l Regulatory Affairs

International Regulatory Affair activities include developing Regulatory Strategies, Comprehensive Documentation, Submission and Archiving of Documents. Regulatory Department also oversees the compliance program, ensuring that all practices conform to the constantly changing regulatory requirements.

Core Competencies

  • Preparation and Submission of Drug Master File (DMF)
  • Preparation of Site Master File (SMF)
  • Generation of Dossier as per European Union and US Guidelines
  • Pre-Inspection Audit
  • Assistance for getting Certificate of Suitability (CoS)
  • Reply to Queries
  • Writing Expert Reports

Activities involved

  • Drafting and editing all sections of DMF
  • Documentation of the following:
    • Drug Substance Characterisation
    • Manufacturing and In-process Controls
    • Stability Study
    • Product Development Reports (PDR)
    • Process Validation Protocol and Reports
    • Method Validation Protocol and Reports
    • Technology Transfer
    • FDA Interactions
    • Chemistry, Manufacture and Control (CMC) information

Expertise In

  • Abbreviated New Drug Application (ANDA) - US
  • European Union Registration - EU
  • Agencia Nationale Vigilenca de Sanitaria (ANVISA) - Brazil
  • Medicines & Healthcare Products Regulatory Agency (MHRA) - UK
  • Therapeutic Goods Administration (TGA) - Australia
  • Medicines Control Council (MCC) - South Africa
  • Commonwealth of Independent States (CIS) Registration
  • Registration in all other regions across the globe

Our expertise also include Preparation and Submission of DMF and CoS, Submission for EU as per EDQM, UK as per MHRA, Australia as per TGA, South Africa as per MCC, Brazil as per ANVISA and CIS Registration besides compilation of dossiers in CTD Format.