Adgyl Lifesciences Private Limited (Adgyl Lifesciences) is a leading multi-faceted contract research organisation with 30+ years of GLP experience ensuring data reliability and accuracy with the highest quality and global customer satisfaction.

Adgyl Lifesciences test facility has a rich history dating back to 1987 when it started its operations under its previous avatars. The test facility has been inspected twice by the US FDA to audit the GLP facility and certain nonclinical toxicology studies that were submitted to US FDA by its clients in support of Phase I clinical trials.

Adgyl Lifesciences offers comprehensive in vivo Pharmacology and Toxicology studies ranging from efficacy studies in multiple therapeutic areas, pharmacokinetics, and metabolism studies, single-dose, repeated dose toxicology, genetic toxicology, safety pharmacology, development and reproductive toxicology, chronic toxicology (3 months to 2 years), carcinogenicity and in vitro skin/ eye studies.

Certifications & Accreditations

In addition to the Pharma and Biotech industries, the non-clinical toxicology/ safety assessment services of Adgyl Lifesciences are availed by global Agrochemicals, Medical Devices, Veterinary health products, Cosmetic, Nutraceuticals, Specialty Chemical, Consumer Product, REACH and Industrial Chemical Industries.

Adgyl Lifesciences has successfully completed, both directly and through its affiliates, 25,000+ Regulatory studies, 2000+ Genetic toxicology, 5000+ acute, 2000+ repeat dose, 400+ reproduction, 65+ Carcinogenicity GLP studies, 90+IND, 60+ GMP campaigns, 11500+ Physico-chemical properties, 1000+ Ecotoxicology studies and submitted data to sponsors worldwide for regulatory submission.

The Pharmacology and Safety Assessment team of Adgyl Lifesciences comprises 200+ staff. A strong R&D organisation with 8 US Board Certified Toxicologists (DABT), 6 European Registered Toxicologists (ERT) and 4 Board Certified Pathologists (Diplomate of Indian Board of Toxicopathology). The team’s average experience is over 15 years with extensive expertise in various areas of preclinical toxicology, safety assessment and a fundamental commitment to quality and data integrity.

Adgyl Lifesciences operates out of two locations in India – Bangalore and Hyderabad, and through its affiliate companies at the same location, also offers Discovery Chemistry, In Vitro Biology, ADME, Bioanalytical services, CMC and CDMO (GMP, non-GMP) for the Pharma / Biopharmaceutical industries and 5 Batch Analysis, Physical-Chemical properties, Residue in crops, Ecotoxicology, Environmental Fate and Behaviour Studies for Agrochemicals and Chemical industries in general.

Hit-to-Lead Optimization to IND/ NDA track Toxicology studies and CMC/ CDMO for Clinical supplies
  • Discovery Services
  1. Medicinal Chemistry – Analytical Chemistry and CADD (Hit-to-Lead, Lead-to-Preclinical Candidate), Synthesis Support, Library Synthesis
  2. In vitro Biology – Biochemical and cellular screening assays (96 and 384 format), Translational studies
  3. In vivo Biology – 100+ validated efficacy animal models
  4. In vitro / In vivo ADME studies – Full tier – I, II and III ADME assays, Met ID
  5. Rodent and Non-Rodent Pharmacokinetic studies

  • CMC/ CDMO – Non GMP and GMP synthesis
  • GLP Toxicology: Genotoxicity, Safety Pharmacology, Acute/ Sub/ Chronic Repeat Dose Toxicity
  • Non-Rodent Toxicology studies (Dog and Minipig)
  • GLP IND Packages
  • GLP NDA-enabling Advanced Development and Reproductive Toxicology (DART) Services
  • GLP Carcinogenicity studies
  • GLP Formulation Analysis and Bioanalysis/ TK Assessment
  • Bioanalysis of Human Clinical Samples
  • In vivo Immunogenicity assessment
  • In-house SEND Format capabilities for Toxicology studies
  • Pharmaceutical analytical services (drug product, drug substance, excipient, intermediates) at USFDA inspected lab