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Drug development
Drug Development Services
Mavens employ over 280 scientists, including 71 study directors, 30 Ph.D. scientists, and 210 scientists with a Master’s degree. Our drug development services are designed to save our clients time and money while also assuring complete compliance with GLP criteria for global regulatory submissions.
Mavens provide a wide range of services for preclinical drug development. Our value proposition for drug development services is based on the following:
- The first facility in India to be certified as OECD GLP compliant was in 1992. (by German Authorities, BfR). BfR, VWA (Netherlands), NGCMA (India), and USFDA have all conducted successful inspections (USA).
- More than 25,000 regulatory studies have been completed for submissions to the USFDA, EMA, MHRA, TGA, Health Canada, and DCGI. Over 80 complete IND packages for overseas applications have been completed.
- Chronic, reproduction, and juvenile toxicity, as well as carcinogenicity studies, are all possible.
- As of 2017, we had completed 65+ carcinogenicity studies (pharma and agro) for submissions to US, EU, and Indian regulators. A large historical control dataset is available.
- Carcinogenicity tests in the Tg RasH2 transgenic mouse model lasted 6 months.
- There are 21 DABT-certified veterinarians and 8 DABT-certified persons in this group (Diplomate of the American Board of Toxicology).
- Strong DMPK and bioanalysis capabilities.
- Develops and validates toxicokinetics methodologies using high-end quadrupole LC-MS/MS instruments and Watson LIMS software.
- Clients' central bioanalytical lab — samples are shipped in from all over the world for regulatory GLP bioanalysis.
- Excellent process chemistry capabilities for producing APIs in preclinical and early clinical development volumes (small molecule).
- Custom chemical synthesis and medicinal chemistry services are available, as well as in vitro and in vivo preclinical DMPK testing.