Regulatory Affairs

 

  • Total Quality Management of Bulk Drugs & Formulations including ISO Accreditation
  • International Regulatory Affairs
  • Upgrading the systems, procedures & Documentation to meet the Requirement of USFDA, MHRA-UK and TGA for Bulk Cemex Pharma Chemicals and Formulations
  • Preparation for Inspection by External Bodies
  • Preparation of Dossiers, DMF’s (Closed and Open parts) and product Dossiers for registering formulation and bulk drugs in various countries
  • Preparation and submission of Dossiers for certification of suitability of the monographs of European Pharmacopoeia
  • Preparation and submission of DM F to Drug Directorate Canada
  • Preparation and submission of Dossiers to MHRA-UK
  • Preparation and submission of DMF in CTD format to US-FDA
  • Preparation and submission of EU-DMF in CTD Format
  • Preparation and submission of DM F as per latest KFDA guidelines
  • All the Dossiers and DMF submissions as per the customer needs for different countries