• 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

Quality Assurance and Compliance

AXIS Clinicals is committed to high quality standards in all areas of our operations. We conduct projects and activities efficiently and in accordance with international quality standards, best practices and ethical principles to ensure that our clients and regulatory authorities are provided the best possible services and products, Click here for poster

AXIS Quality Management System

To comply with international quality standards, we have designed a Quality Management System. This system ensures that all operations and projects adhere to local and international regulatory requirements and guidelines e.g. Principles of Good Clinical Practice and ICH guidelines. This consists of the following components:

  • Quality assurance
  • Well structured organization with highly qualified personnel
  • Detailed Standard Operating Procedures (SOPs) describing responsibilities and duties
  • Regular audits
  • System improvement and consultancy

AXIS Quality Assurance Department

Our Quality Assurance (QA) department is an independent unit reporting to the CEO. The department’s main focus is the continual improvement of AXIS Quality Management System to ensure the required quality fulfillment.

 

Our SOPs contain quality control mechanisms and our Quality Management System requires that SOPs (either ours or yours, if requested) are followed to ensure Good Clinical Practice compliance.

Our clients regularly conduct audits of our well structured Quality Management System. We have been successfully approved in all external client audits. Our QA team conducts regular Internal Audits in all areas of our business to maintain our excellent reputation for quality and compliance.

Involved at every step of clinical development, AXIS QA staff ensures that your projects receive the highest level of quality and efficiency. System improvement and consultancy is given on a continuous basis to all our personnel and to clients as requested. Our QA personnel maintain an optimal level of knowledge through ongoing continuing education and regular participation at QA and other conferences.

AXIS Clinicals has in-house capabilities to perform:

  • Site Audits
  • Systems | Process Audits
  • Vendor Audits
  • Document Audits (Protocol, Clinical Study Reports & essential Clinical Trial documents)
  • GCP compliance review
  • IRB | EC audits
  • On-site investigator audits
  • Drug accountability reviews
  • Database audit
  • Study document reviews
  • Internal Audits for Area Specific SOP compliance

All our QA systems are compliant with all applicable local & international regulations.

 

 

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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