AXIS Clinicals Announces Successful Completion Of 13th U.S. FDA Audit
3/27/2014 1:58:14 PM
Hyderabad, INDIA – AXIS Clinicals Limited, the leading Clinical Research Organization (CRO), announces today that its Hyderabad, India based Clinical Pharmacology Units (CU-I and CU-II) successfully completed its 13th US FDA Audit without 483s / observations. US FDA Investigator audited the First-to-File studies for one of AXIS Clinicals’ sponsor. The audit covered the review of several studies, general processes and systems inspection.
The latest US FDA Audit with NO 483’s is a resounding success for AXIS Clinicals Team. Having a successful US FDA audit for the First-To-File product, along with the Brazilian ANVISA, UK MHRA, France-AFSSAPS, Turkey MOH and NABL certification, demonstrates that AXIS Clinicals has attained the Quality Standards laid by international regulatory bodies.
AXIS Clinicals continued successful audit track record confirms that the company's quality system meet the requirements established by the US, Canada, Europe, Brazil, Australia, South Africa, Turkey, Malaysia and other international regulatory authorities.
About AXIS Clinicals
AXIS Clinicals Limited is a Contract Research Organization headquartered in Hyderabad, India with the global footprint of operations in United States, Mexico and Thailand, committed to serving the biopharmaceutical industry with the global standards and most accurate results. AXIS Clinicals specializes in the conduct of Bioequivalence / Bioavailability studies, Phase / Clinical Trials and bioanalysis for innovative pharmaceutical, biotech and medical device companies. AXIS Clinicals has completed 1500+ studies for global regulatory submissions.
AXIS Clinicals has the world-class infrastructure with 292-bed clinical facility and a co-located bioanalytical laboratory in Hyderabad, India.
About First-To-File product:
The first-to-file status comes with 180-day marketing exclusivity (from the date of approval of the ANDA). During this exclusivity period, the first-to-file generic company can realize enormous profits on the sale of the generic drug before other generic product enter the market.
AXIS Clinicals Limited
Web : www.axisclinicals.com
Email : BD@axisclinicals.com
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