• 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

Accreditations

National/International Accreditations
AXIS Clinicals has been audited and approved by various regulatory authorities that include:

  • Drugs Controller General of India
  • USFDA
  • EMEA
  • MHRA
  • AFSSAPS, France
  • ANVISA, Brazil
  • MCC, South Africa
  • MOH, Turkey
  • MOH, Mexico
  • Thailand FDA
  • WHO
  • GCC-DR ( Gulf Central Committee for Drug Registration)

 

Regulatory Inspections & Approvals


Medical Diagnostic Lab of AXIS Clinicals has been approved and accredited by NABL on annual basis. Besides study submissions to more than 25 countries, AXIS Clinicals has also been approved for submission of studies to MOH Canada, NPCB Malaysia, Australia, South Africa and WHO.

 

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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