Preclinical Phase / Pharma/Biotech/ Agrochemicals/Specialty Chemicals/Consumer Product/REACH Chemicals/Veterinary products

Safety Assessment studies conducted are compliant with OECD GLP [C (97) 186/Final], USFDA (21CFR Part 58) and the study guidelines prescribed by the international regulatory agencies including ICH, ECHA, MHRA, EMA, OECD, EPA, JMAFF, JMHW and other guidelines.

Our broad spectrum of GLP and non-GLP service offerings, along with our experience of over 3 decades, ensures meeting the current global safety testing requirements. Adgyl experienced team enables study completion in the shortest possible time-period such that regulatory submissions can be expedited.

Adgyl Lifesciences offers full range of Safety Assessment Regulatory Tox, IND enabling CMC and PharmTox packages, agrochemical/pesticide toxicology, REACH studies etc. It also offers both cGMP material for your early clinical development, late clinical development (for niche molecules) and long term non-clinical safety studies for NDA submission.

We have successfully submitted 1500+ Physico-chemical properties, Ecotoxicology studies and Environmental Risk Assessment Tox Studies, supported 90+ IND packages for submission to regulatory agencies across the world including USEPA, Mexico, Brazil, USFDA, ICH, MHA and EMA. Adgyl is a GLP and AAALAC accredited lab and successfully audited by the USFDA (2012 and 2016) for GLP studies submitted as part of IND packages.

Provantis system is used in toxicology including reproductive toxicology and pathology areas for on-line data capture.