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..