10 July 2019 | News
The said approval is the first in India for any independent laboratory without an animal house.
image credit- cio.com
Mumbai based Accutest Biologics Private Limited (ABPL), a leading CRO for high-quality Biochemical characterization and Bioanalytical services supporting preclinical and clinical development of Biologics and Biosimilars, has received the prestigious OECD-Good Laboratory Practice (GLP) certification. The said approval is the first in India for any independent laboratory without an animal house.
The GLP Certification is in recognition of the high-quality, regulatorily compliant services rendered by Accutest in validating the processes and documentation systems followed at the test facility. "The certification places Accutest in a select league of CROs that have been awarded such a global honour. It is a matter of pride and privilege for Accutest not only to serve the biopharma industry with established credibility but also to get recognized in all the OECD member countries for mutual acceptance of data," commented Dr. Satish Sawant, Founder of Accutest.
"ABPL has been in existence for more than 5 years and conducted various studies for submissions across USFDA, EMA, DCGI and ANVISA. This approval will enable us to advance rapidly as a global service provider servicing the biopharmaceutical industry while maintaining high-quality deliverables," said Dr. Mallikarjun Dixit, President R&D and Test Facility Management
ABPL is a subsidiary of Accutest Research Laboratories Pvt. Ltd., a well-established player in the Clinical CRO Industry for over two decades having dominant presence in Bio Availability and Bio Equivalence space with more than 100 International Accreditations. It is a state-of-the-art facility offering a one-stop solution for analytical and bioanalytical services from early-stage characterization to the late-stage clinical evaluation of biologics. Bioanalytical services include Pharmacokinetics, Pharmacodynamics and Immunogenicity assessment of Biologics, biotherapeutics, biosimilars, vaccines and non-biological complex drugs using high-end assay formats ELISA, MSD and GYROS. ABPL also provides in vitro activity/potency and bioassays services for evaluating the biological activity besides toxicokinetics and related services.