Advinus Pharma Services

Advinus - Your Trusted Partner

Advinus Therapeutics is a multi-faceted contract research organization which has played a critical role in pioneering drug discovery in India and has along the years developed expertise and capabilities across a wider spectrum of services supporting companies in their pre-clinical and early stage research. It is well recognized not only amongst its clients, but also within its peers and the regulators. Advinus can boast of several firsts to its credit -

The First GLP certified test facility in India

The First GLP test facility audited by USFDA in India

The First AAALAC accredited animal house facility in India

Over the years, data generated at the Advinus facility has been successfully submitted by sponsors to regulatory agencies around the world including USFDA, Health Canada, EMA, MHRA (UK), HSA (Singapore), Medsafe (New Zealand), DCGI (India), Australia and AEMPS (Spain).

Advinus has demonstrated its commitment to quality by receiving approvals from various GLP authorities including BfR (Germany), WnV (The Netherlands), NGCMA (India). The facility is also certified ISO 17025:2005 for biological testing.

Advinus has a track record of developing over 50 INDs for global regulatory submission by sponsors. We have conducted 10,000 regulatory studies for sponsors worldwide, extending services to the global pharma, agro and other allied industries.

We have unparalleled combination of staff experience and laboratory resources. Advinus’ Chemistry Services support pre and early clinical development programs by providing services in the areas of focused Library Synthesis, Custom Synthesis to generate a few grams to few hundred grams of desired NCE for exploratory studies and chemical development services. The DMPK department has broad capabilities to support various drug discovery and development studies. Advinus offers a wide range of Toxicity Studies in several species. We have an impeccable record of conducting novel studies like Intravenous Infusion studies, Local Lymph Node Assay (LLNA) and Juvenile Toxicology studies. We also perform toxicology studies for biosimilar molecules. We have a central bioanalytical lab for sample analysis for preclinical and clinical samples. Samples from around the world are shipped in for regulatory analysis.