cGMP QC(batch/ lot release) Testing and API Impurity Testing/ Qualification

Advinus Therapeutics, a leading contract research organization based in India, has a successful track record of conducting and submitting over 8500 GLP regulatory studies. We have successfully completed several GMP projects with in-house GMP QC testing using both pharmacopeial and in-house developed and validated methods. Our focus on quality and timely delivery at competitive prices has helped establish us as a successful partner and preferred vendor to the world's largest and fastest growing companies.

Our Analytical labs are well-equipped to support the isolation and purification of impurities by preparative HPLC, as well as their complete analytical characterization and structure elucidation using LC-MS, ICP-MS and NMR (¹H, ¹³C, 1D, 2D, NOE, DEPT).
We offer custom synthesis capabilities of the identified impurities or metabolites.
For novel impurities/ metabolites exceeding the qualification threshold, our facility has GLP-certified safety testing toxicology labs where these can be qualified:

Genotox studies, including in vitro point mutation and chromosomal aberration
Sub-chronic studies in mammalian species (rodents) as per ICH Q3A guideline

With over 50 successful IND packages and their supporting CMC services submitted to agencies around the globe, our track record speaks for itself.
For more information visit our website www.advinus.com

Our mailing address is:
Advinus Therapeutics Ltd.
21&22 Phase II, Peenya Industrial Area
Bangalore, 560058, India
Ph: +91-80-29394959

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