iVRS

iVRS News

Successfully Completed 100 + Extractable and Leachable (E & L) Studies.

Extractable & Leachable Studies conducted at iVRS has been approved by USFDA and Health Canada.

In Vitro Release Test (IVRT) Studies conducted at iVRS has been accepted by Saudi Food and Drug Authority (SFDA).

Successfully completed PK based bioequivalence study of Cladribine in RRMS Patients for Jordan Food and Drug Administration (JFDA) submission.

Rich Experience in Handling Global Biosimilar Studies.

Successfully Completed Global Ophthalmology Device Study.

Our Process and Systems are ISO 9001 & ISO 27001 Compliant.

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Dr. D Prabakaran M.Pharm, Ph.D

Sr. Vice President – Technical Operations

Dr. Prabakaran is doctorate in pharmaceutical sciences from Dr. Hari Singh Gour University, Sagar, MP, and he started his career as formulation scientist in 2004. In 2006, he moved into clinical research and served generic pharmaceutical industry for 15 years in the area of formulation sciences, bioequivalence, late phase clinical studies, biopharmaceutics, in vitro-in vivo correlation, biostatistics, in vitro bioequivalence studies, clinical studies of derma, ophthalmic & pulmonary products, analytical and bioanalytical sciences.

His experience with respect to clinical research/in vitro studies entirely with regulated market like US, Europe, Australia, etc., and faced various regulatory audits. He is well versed with the regulatory expectations and up to date with regulatory guidance and newer approaches on generic drug development.


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Location

Bangalore, India

Call Us

+91 80 45500700

Email Us

info@ivrs.org.in