Pharmaceuticals formulation and Active Pharmaceuticals Industries

Pharmaceuticals formulation and Active Pharmaceuticals Industries

Various Regulatory Services concerning to the State Licensing Authorities (SLA)

  • Various QMS Systems Development and Implementation with respect to applications for Manufacturing Licenses under
    • Form 25, Form 25-A, Form 25-B
    • Form 28, Form 28-A, Form 28-B, Form 28-D, Form 28-DA (Drugs/Biologicals)
    • Form COS-8 (Cosmetics)
    • Form 25-D (Ayurveda)
  • Various QMS Systems Development and Implementation with respect to
    • State GMP
    • WHO GMP
    • Written Confirmation (Drugs/Biologicals)
  • Applications for Test License under Form 29
  • Applications for Additional Product Approvals
  • Applications for Technical Person Approvals
  • Applications for Various Certificates like Free sales certificate, COPP, Market Standing Certificate, Manufacturing and Marketing Certificate, Neutral Code, Non-Conviction Certificate, Performance Certificate, FFS technology Certificate, BFS Technology Certificate etc.
  • Applications for Public Testing Laboratories under Form 37
  • Applications for Loan License

Various Regulatory Services concerning to the Central’s Zonal Licensing Authorities (CLA-Zonal CDSCO)

  • Applications for Test License under CT 10, Form 11, CT 12, CT 13, CT 16
  • Applications for Dual Use NOC for Traders and/or Manufacturers
  • Applications for WHO GMP Approvals
  • Applications for Written Conformation for APIs
  • Applications for BA-BE Study Centre Approvals

CRO (Clinical Research Organisation) Registration – under Form CT07B

Various Regulatory Services concerning to the Central Licensing Authorities (CLAA CDSCO)

  • Activities for Manufacturers
    • Applications for Manufacturing of Investigational New Drugs under CT 21 for APIs and/or Finished Formulations for Drugs, Biologicals, Vaccines etc.
    • Applications for Manufacturing of New Drugs under CT 21 for APIs and/or Finished Formulations for Drugs, Biologicals, Vaccines etc.
    • Applications for Manufacturing of Subsequent New Drugs including of New Dosage Form, Additional Strength, Additional Indication under CT 21 for APIs and/or Finished Formulations for Drugs, Biologicals etc
    • Applications to Manufacture New Veterinary Products under Form 44
    • Applications to conduct Phase I, Phase II, Phase III or Phase IV Clinical Trials under CT 04.
    • Applications to conduct BA/BE Studies under CT 05.
    • Applications to conduct BA/BE Studies for Export Purpose.
  • Activities for Importers
    • Applications for Import of New Drugs under CT 18 for APIs and/or Finished Formulations for Drugs, Biologicals, Vaccines etc.
    • Applications for Import of Subsequent New Drugs including of New Dosage Form, Additional Strength, Additional Indication under CT 18 for APIs and/or Finished Formulations for Drugs, Biologicals etc
    • Applications to Import New Veterinary Products under Form 44
    • Applications to Import Registration under Form 40 and Import License under Form 10.
    • Applications to conduct Phase I, Phase II, Phase III or Phase IV Clinical Trials under CT 04.

Know more services

Plan Design and Development

(Pharmaceutical APIs and/or Pharmaceutical Formulations compliance to WHO-GMP/PICS/EUGMP/UK MHRA)

Medical Devices and In-Vitro Diagnostics

Applications for Manufacturing Test license under Form MD 12 (Medical Devices/IVDs) – CDSCO

Applications for Manufacturing License under Form MD 9 (Medical Devices/IVDs) – CDSCO

Cosmetics

Applications for Manufacturing License under COS 5

Applications for Additional Product Approvals