Friday, 6 July 2012

AXIS Clinicals announces successful completion of US FDA Audit

AXIS Clinicals announces successful completion of US FDA Audit for Patient Population Clinical Bioequivalence study
Friday, 08 June 2012

Hyderabad, INDIA : AXIS Clinicals Limited, India’s Premier Clinical Research Organization (CRO), announces today that it has successfully completed its 9th US FDA Audit for Patient Population Clinical Bioequivalence study.

AXIS Clinicals successful audits confirmed that the company's quality system was found to meet the requirements established by the US, Europe and other international regulatory authorities.

P. Sarath Chandra Reddy, Managing Director of AXIS Clinicals, said, "The successful US FDA Audit is a resounding success and we are delighted and proud of the achievement. Having a successful US FDA audit along with the US FDA, Brazil ANVISA, UK MHRA, France AFSSAPS, NABL and ISO 9001:2000 certification, means that AXIS Clinicals has attained the Quality Standards laid by regulatory bodies and we will ensure the Best Quality with Highest Standards - All The Time. These are very exciting times for all of us."
"We are proud to announce this FDA audit outcome for patient population clinical trial conducted by AXIS Clinicals, ensuring once again our commitment to the highest standards of quality," said P. Sarath Chandra Reedy, Managing Director of AXIS Clinicals Ltd. "We give the preference not only to the quality of our specialized services, but also on their continuous improvement for customer delightness. This achievement is the enduring result of a high level of dedication to achieve total customer satisfaction through unsurpassed service, on-time delivery, and report submissions that meet or exceed our customers and applicable regulatory expectations for quality and performance.

About AXIS Clinicals Limited

AXIS Clinicals Limited is a Clinical Contract Research Organization committed to serving the biotech, pharmaceutical and Generics industry with the global standards and most accurate results. AXIS has completed more than 1300 trials on various therapeutics classes of drugs, including; Lipid lowering agents, Anti-Diabetic, Anti-Depressants, Antibiotics, NSAIDs, anti-epileptic muscle relaxants, hormones, cardiac drugs, psychotropic & narcotics drugs, antiretroviral (ARVs), Oncology products, Ophthalmology products and oral contraceptives.
Within short span, AXIS Clinicals Limited has achieved the milestone of completing 1300+ clinical studies, 300+ ANDA study completions and 100+ product approvals from various regulatory agencies. Several regulatory audits from global competent authorities are the testament to the professionalism and dedication to quality studies.
AXIS Clinicals Limited has the state-of-art facilities for Bioequivalence / Bioavailability studies and also provides the Clinical Trials services like Phase II- IV services, Clinical Data Management, Project management, Site Management, Post-Marketing Surveillance.
AXIS Clinicals widen its global footprint with starting the Mexico operations for the Bioequivalence / Bioavailability studies and Clinical Trials services.

Please contact Business Development Team at or at +91 (40) 4040 8044

For any further information, please contact:

Corporate Communications
AXIS Clinicals Limited
1-121/1, Miyapur,
Hyderabad 500 049, INDIA
Phone +91 (40) 4040 8044

AXIS Clinicals Ltd is Clinical Research Organization committed to serving the global pharmaceutical and biotech industry

AXIS Clinicals Ltd is Clinical Research Organization committed to serving the global pharmaceutical and biotech industry with the global standards and most accurate results. In compliance with ICH/GCP/GLP guidelines, AXIS Clinicals is India’s premier Clinical Research Organization. We have completed 1300+ studies for all regulatory bodies like EU, US FDA, WHO, Canada, Brazil ANVISA, MCC South Africa, France, TGA Australia, Russia, Thailand and India.
AXIS facility has been successfully audited &/or accredited by US FDA, UK MHRA, Brazilian ANVISA, India (DCGI), AFSSAPS, NABL and ISO 9001:2000.

Audit details:

  • 8 US FDA Audits (recent audit in October 2011)
  • Recently completed US FDA audits with 'NO' 483’s
  • Turkey MOH Audit (Dec 2011)
  • 2 UK MHRA audits with NO major findings / observations (Recent audit Oct 2011)
  • France AFSSAPS audit - Sponsor received the product approval
  • Brazil ANVISA – 3 successful audits
  • ISO 900:2000
  • NABL approval for Clinical Investigational Unit
  • Product approvals (for sponsors) from Health Canada, WHO, AFSSAPS, US FDA, Europe, Australia, Brazil & DCGI Regulatory Agencies

In addition to BA/BE experience, we have a group of highly skilled clinical research professionals to conduct Clinical Bioequivalence studies and phase 2 to 4 clinical trials in India.

Our core clinical capabilities includes Ophthalmology (PK/PD studies), Oncology (lung, breast, and colorectal), orthopedic (chronic low back ache, arthritis, osteoporosis), cardiology (pulmonary arterial hypertension, essential hypertension, and acute myocardial infarction), and vaccine. The team has an experience of working with more than 360 clinical investigators across 110 research sites. Our services include medical writing, thorough project-, site- including monitoring and data-management.