• 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

Regulatory Services

Regulatory Services is an integral component of our services portfolio. The independent team for regulatory services helps you navigate complex regulatory requirements throughout your product’s development lifecycle. We have an in-depth knowledge of local regulatory procedures and dedicated and effective liaisoning with various regulatory agencies that ensures high efficiency in the Clinical Trial approval process.

In order to receive regulatory approval, you invest big money and years in drug development. Never let the intricacies of filing across multiple countries delay your launch. Banking on AXIS Clinicals’ integrated cross-functional expertise and flexible sourcing options, our clients enhance the probability of successfully registering their products with Drugs Controller General India and Directorate General of Foreign Trade.

AXIS Clinicals’ services include but not limited to:

  • Offer support on Indian regulatory environment & requirements
  • Compiling dossiers
  • Executing regulatory submissions
  • Preparation & submission of complete range of regulatory documents for obtaining:
    • Approval to conduct clinical trial in India
    • Approval to import Test Drug
    • Approval to export Biological Samples
    • Liaisoning and Obtaining registration documents in the interest of clients
    • Continuous follow-up post submission with regulatory authorities
    • Renewal of Import license
    • Safety reporting

Regulatory offerings in AXIS Clinicals has successfully completed over 38 audits from Indian & International regulatory agencies, 50+ sponsor audits from Indian and International clients and study submissions have been made to more than 50 countries.

All the services are executed in strict compliance with regulatory and ICH GCP requirements.


 

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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