USFDA completes audit at Jeevan Scientific Technology’s facility

18 Jan 2018 Evaluate

The US Food and Drug Administration (USFDA) has completed the audit of Jeevan Scientific Technology’s clinical pharmacology centre facility with one study specific observation (One 483). The company is working on addressing this observation within the stipulated timelines.

Earlier, USFDA had conducted an un-announced audit of the company’s clinical pharmacology centre facility. The purpose of this audit was to review the BA/BE studies. The auditors started the review on January 9, 2018 and completed on January 12, 2018.

Jeevan Scientific Technology (JST) provides a range of clinical research services for healthcare/pharmaceutical industries in India and internationally. Its clinical research services comprise bio-analytical, clinical data management, biostatistics and statistical programming, medical writing, pharmacovigilance, regulatory affairs, quality assurance, and project management services, as well as clinical operation and scientific writing services.


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