Regulatory Services

Regulatory Services offered:

  • Preparation and filing of Registration Dossiers for submission to various Regulatory Agencies all over the world (including eCTD, CTD format & ACTD Format).
  • Drug Master File (DMF) compilation for APIs and Packing materials.
  • Assisting the clients for development of new products and data generation in line with country specific registration guidelines.
  • Assistance in responding to queries for submission to the Regulatory Agencies.
  • Regulatory Assistance in Post-Approval compliance
  • Assisting the clients to upgrade the existing products by additional data generation to the requirements of updated regulatory requirements (Gap analysis).