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WHAT WE CAN DO

  • 1. Preparation of techno- economic pre-feasibility project reports
  • 2. Trading, sourcing & knowledge sharing on market trend/developing a quantitative market map and model for the entire product category.
  • 3. Fabrication & supply of plant & machineries and processing equipments
  • 4. Erection & installation of the plant & machineries, pipeline & its  accessories supply and connection
  • 5.Processing technology transfer
  • 6.Standard operating procedure preparation (SOP)
  • 7.Pharmaceutical clean room design and supply
  • 8.Drug master file (DMF) preparation
  • 9.US and Canadian drug master file (DMF) for API & Excipients
  • 10.Project designing as per regulatory requirements of ,Schedule M of drugs & cosmetics act & WHO GMP guide lines, and Fssai regulations
  • 11. Preparation of CTD – Dossiers (common technical dossier) submitted to Food & Drug Authority
  • 12. Preparing technical master file for submission in other countries for approval.
  • 13. eCTD Electronic Common Technical Document submissions on all types of drug products
  • 14. Assistance for recruitment of management regulatory staff as well as down line regulatory professionals
  • 15. Representation of API manufacturing units of other countries in India
  • 16. Market research and survey reports preparation
  • 17. Supply and commissioning of complete project on turnkey basis
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