09 July 2019 | News
Validation is granted first time in India to an independent laboratory that does not host a pet shop
Image Courtesy: prnewswire
Accutest Biologics Private Limited (ABPL), a leading India-based contract research company (SRC) dedicated to biochemical characterization and high-quality bioanalytical services that accompany developments pre-clinical and clinical biologics and biosimilars, obtained the prestigious OECD Good Laboratory Practice (GLP) certification. This is the first time in India that this validation is granted to an independent laboratory that does not host a pet shop.
GLP certification aims to recognize high-quality, Accutest-compliant services by validating the documentation processes and systems implemented at the test centre. ”With this certification, Accutest is now part of a closed circle of SRC that has received this global distinction. For Accutest, it is a pride and a privilege to work for the biopharmaceutical industry with established credibility and to be recognized in all other OECD member countries, facilitating the mutual acceptance of data” said Dr Satish Sawant, founder of Accutest.
"ABPL has been in existence for over 5 years and has conducted various studies for submissions to USFDA, EMA, DCGI and ANVISA. This validation will enable us to progress rapidly as a global provider of services in the biopharmaceutical sector while maintaining the high level of quality of our deliverables, “said Dr Mallikarjun Dixit, R & D President and Test Centre Management within the biopharmaceutical industry, ABPL.
ABPL is a subsidiary of Accutest Research Laboratories Pvt. Ltd., a well-established player in the clinical CRS sector for over twenty years and enjoying a dominant position in the field of bioavailability and bioequivalence with more than 100 international accreditations. Its state-of-the-art facility provides a complete solution for analytical and bioanalytical services, from the early stage of characterization to the final stage of clinical evaluation of biologics. The proposed bioanalytical services include the pharmacokinetics, pharmacodynamics and immunogenicity evaluation of biologic and biotherapeutics, biosimilars, vaccines and non-biological complex drugs using state-of-the-art ELISA, MSD and GYROS test formats in vitro and biological assays to evaluate biological activity.