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We provide the following services :

  • CGMP / Quality System Auditing

  • Internal GMP Audit

  • Analytical Laboratory Audit

  • Quality System Design & Management

  • Stability Program Design / Implementation
  • Regulatory Submission Preparation for
    • Drug Master File (DMF) in CTD
    • Certificate of Suitability (COS) Dossiers in CTD

  • Standard Operating Procedure (SOP) Development

  • Revised Schedule 'M' , WHO - GMP,
    UK-MHRA , Australia - TGA , PIC/s etc. implementation