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About Us

About Us

Incorporated in June 2002.

A leading provider of Quality, Regulatory and Project consultancy services for compliance to USFDA, EDQM, EU GMP, MHRA, TGA, MCC, MFDS (KOREAN FDA), COFEPRIS, HEALTH CANADA. PMDA and other regulatory agencies for API, BIOTECHNOLOGY and FORMULATIONS manufacturing pharmaceutical companies.

Why Choose Us

We have an enviable track record of more than 135 successful USFDA/EDQM/COFEPRIS /MFDS (KFDA)/Health Canada and other International Regulatory Inspections/approvals & Greenfield and upgradation projects.

  • > 200 DMF
  • >100 CEPs granted
  • 135 International Inspections that includes
  • 65 US FDA inspections
  • >30 EDQM/EUGMP
  • 40 OTHERS(COFEPRIS , ANVISA , PMDA , MFDS, etc. )
  • 20 Projects ( Green Field & Turnkey )
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Why Choose Us?

We have an enviable track record of more than 135 successful USFDA/EDQM/COFEPRIS /MFDS (KFDA)/Health Canada and other International Regulatory Inspections/approvals & Greenfield and upgradation projects.

  • > 200 DMF
  • >100 CEPs granted
  • 135 International Inspections that includes
  • 65 US FDA inspections
  • >30 EDQM/EUGMP
  • 40 OTHERS(COFEPRIS , ANVISA , PMDA , MFDS, etc. )
  • 20 Projects ( Green Field & Turnkey )

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