• AXIS Clinicals successfully completes 20th US FDA audit (April 2017)
  • AXIS Clinicals successfully completes 8th ANVISA – Brazil audit (August 2017)
  • AXIS Clinicals successfully completes MCC South Africa audit (March 2017)
  • AXIS Clinicals successfully completes GCC audit (February 2016)
  • AXIS Clinicals successfully completes 7th ANVISA – Brazil audit (March 2015)
  • AXIS Clinicals successfully completes WHO audit (March 2015)
  • AXIS Clinicals successfully completes 3rd MHRA audit (Sep 2014)
  • 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

  • Thai FDA approves AXIS Clinicals Bioanalytical facility. Dates : Jan.21st – Jan.25th, 2014. 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..

Copyright Axis Clinicals - All Rights Reserved