Hyderabad, INDIA AXIS Clinicals Limited, India s Premier Clinical Research Organization (CRO), announces today that it has successfully completed its 6th US FDA Audit without 483s.
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 latest US FDA Audit with NO 483 s 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.”
AXIS Clinicals Limited is a Contract Research Organization committed to serving the biopharmaceutical industry with the global standards and most accurate results. AXIS has completed more than 1200 studies 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, ARVs and oral contraceptives.
