Express Pharma

LifeSan Clinical Research receives zero 483 observations from US FDA

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The observation signifies compliance and conformance to applicable GCP regulations

LifeSan Clinical Research, the clinical research division of Centaur Pharmaceuticals was audited by the US FDA and was concluded with zero 483 observations which signifies compliance and conformance to applicable GCP regulations. LifeSan has successfully faced six inspections from US FDA; two inspections from MHRA/ EMA and one inspection from MCC, South Africa, in its 12 years of existence.

It undertakes bioavailability/ bioequivalence studies, which are mandatory for generic drug approval process and phase II/III clinical trials. Since inception, LifeSan has submitted many studies to regulatory agencies of US FDA, EMA, MCC South Africa and TGA, Australia as well as CDSCO, the Indian Drug Regulatory Authority, including successful conduct of phase II and III clinical trial of a new chemical entity [NCE].

SD Sawant, MD, Centaur Pharmaceuticals said, “The zero 483 observations to our clinical research division, LifeSan Clinical Research is yet another feather in our cap. We are happy with this significant development not only for Centaur but also for the Indian pharmaceutical industry. In addition to US FDA accreditation, the said facility also conforms to MHRA (UK), TGA (Australia), Health Canada, MCC (South Africa) and WHO-GMP standards.”

 

 

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