Regulatory Affairs
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  • Total Quality Management of Bulk Drugs & Formulations including ISO Accreditation
  • Regulatory Affairs
  • Upgrading the systems, procedures & Documentation to meet the Requirement of USFDA, MHRA-UK, TGA and other regulatory requirements
  • Preparation for Inspection by External Bodies
  • Preparation, review and submission of DMF’s(CTD and ECTD format), Dossiers, and product Dossiers for registering in various countries