Advinus offers a comprehensive range of preclinical drug development services. Our drug development services value proposition is based upon;
- First facility in India (1992) certified as compliant to OECD GLP (by German Authorities, BfR). Multiple successful inspections by BfR, VWA (The Netherlands), NGCMA (India) and USFDA (USA)
- Executed more than 10,000 GLP studies for USFDA, EMA, MHRA, TGA, Health Canada and DCGI submissions. Completed 50 complete IND packages for international submissions
- Capabilities for chronic, reproduction, and juvenile toxicity, and carcinogenicity studies
- Executed 60 carcinogenicity studies as of 2017 (pharma and agro) for submissions US, EU and Indian regulators. Extensive historical control dataset
- Experienced in 6 month carcinogenicity studies in Tg RasH2 transgenic mouse model.
- Includes 21 trained veterinarians and 8 people certified as DABT (Diplomate of the American Board of Toxicology)
- Strong capabilities in DMPK and bioanalysis
- Equipped with high end quadrupole LC-MS/MS instruments and Watson LIMS software; develops and validates methods for toxicokinetics
- Central bioanalytical lab for clients – samples from around the world are shipped in for regulatory GLP bioanalysis
- Excellent process chemistry capabilities to produce APIs in quantities suitable for preclinical and early clinical development (small molecule).
- Offers custom chemical synthesis and medicinal chemistry services which may be supplemented by in vitro and in vivo preclinical DMPK testing, as needed.
Advinus has close to 280 scientists including 71 study directors, 30 PhD level scientists and 210 scientists with Master’s level qualification. Our drug development services are geared towards time and cost savings for our clients, while ensuring full compliance to GLP requirements for global regulatory submissions.