At Aragen, we are committed to be a ‘one stop partner’ for our clients’ IND filing needs. GLP safety assessment is an important part of the drug discovery process, offering critical data for timely pipeline decisions for our clients. We provide these services from our facility in Pune, which is operated by our subsidiary, Intox Private Ltd. Intox’s OECD GLP and NGCMA certified facilities have a proven track record of conducting a wide range of safety assessment studies like mutagenicity, acute, sub-chronic, chronic, reproductive, environmental studies with analytical and bio-analytical capabilities in compliance with global regulatory requirements of US, EU, UK, Japan, South America, Australia, India among others. These studies are conducted in a variety of animal species including rats, mice, guinea pigs, dogs and non-human primates.
The combined capabilities of Aragen and Intox will enable us to advance promising molecules from in vivo pharmacology stage to IND enabling stage. We can now provide integrated services across CMC and safety assessment to rapidly advance our customers IND programs across the pre-clinical and clinical development stages. Intox’s GLP certified facility also routinely supports agro-chemical and chemical industries for their safety data generation required for submission to regulatory agencies.
Our Safety Assessment solutions
Testing programs can be designed to support product registration as per National and International requirements recommended by OECD, US FDA / EPA, EMA, WHO, ICH, EC, ISO, USP etc. and authorities in India (CDSCO, RCGM-DBT, CIB-RC). Read more