• AXIS Clinicals successfully completes 25th US FDA audit (November 2018)
  • AXIS Clinicals successfully completes 4th MHRA audit (June 2018)
  • AXIS Clinicals successfully completes 2nd WHO audit (December 2017)
  • AXIS Clinicals successfully completes AEMPS Spain (December 2018)
  • AXIS Clinicals successfully completes INFARMED Portugal (June 2018)
  • AXIS Clinicals successfully completes NPRA Malaysia (June 2018)
  • AXIS Clinicals successfully completes GCC audit (February 2016)
  • AXIS Clinicals successfully completes MCC South Africa audit (March 2017)
  • BA-BE studies conducted at AXIS Clinicals are accepted by Chile – ISP

News & Media

Regulatory Inspections and Accreditations:

AXIS Clinicals Limited conducted bioequivalence studies to support marketing authorization for various regulated markets including US FDA, Europe, TGA, ANVISA, WHO, DCGI, Health Canada etc. for various sponsors. Our facility has been audited and approved by various global regulatory agencies and accreditation bodies and the details were described in the following table for 2013.

For a summary of regulatory inspections and approvals Click here

  • AXIS Clinicals announces successful completion of US FDA Audit, September 2019. Click here

  • ANVISA – Brazil: Dates: August 5-8th 2013, Approved for all phases

  • NABL: Dates: May 11-12th 2013, Approved for reassessment

  • USFDA: Dates: August 6-8th 2013, No Form 483 – all phases

  • USFDA: Dates: April 2017, AXIS completed 16th Audit by US FDA Click here

Fact sheet

  • 2,600+ clinical studies completed since inception
  • 350+ bioanalytical methods developed
  • 50+ successful Regulatory audits
  • Global footprint of operations with sites in India, U.S & Mexico.
  • Two clinical facilities (Hyderabad & Ahmedabad) in India
  • 100+ National and International Pharma/Biotech Sponsor companies working with AXIS
  • US FDA : 500+ approvals, EMEA : 100+ approvals, Canada : 50+ approvals, Australia : 50+ approvals
  • 500+ experienced employees working globally
  • Huge database of patient population in various therapeutic areas viz. Cardiology, Opthalmology, Schizophrenia, Diabetology, Oncology. Orthopedics etc..

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