Adgyl Lifesciences provides comprehensive services of data generation for the registration of Veterinary Pharmaceuticals (which includes Pharmaceuticals, Vaccines and Biologics) in regulated markets as per the Veterinary International Conference on Harmonization (VICH) requirements.
Adgyl Lifesciences helps the Animal Health and Veterinary Pharmaceutical market by working on innovative drugs and vaccines by performing Safety studies in food-producing and companion animals. This data is required for Investigational New Animal Drug (INAD) and New Animal Drug Application (NADA) submissions.
Adgyl Lifesciences has CMC facilities for the synthesis of small molecules (kilo lab) and GMP CDMO facilities to produce clinical APIs. The company also provides services for the Bioanalysis of Clinical samples as per GLP.
| SI. No. | Studies Required for Veterinary Pharmaceutical Product used in Food-Producing Animals |
|---|---|
| 1 | Target Animal Safety Chicken |
| 2 | *Target Animal Safety Cattle, Dog & Swine |
| 3 | Genotoxicity Testing – Ames, In Vitro and In Vivo Chromosomal Aberration |
| 4 | Repeated Dose (28 to 90- Day) Toxicity Study in Rat |
| 5 | Repeat-Dose (28 to 90-Day) Toxicity Study in Dog/ Swine |
| 6 | Two-Generation Reproduction Toxicity Study in Rat |
| 7 | Developmental Toxicity Testing in Rat – (Rabbit: Optional) |
| 8 | Chronic Toxicity Study Rat – (Dog: Optional) |
| 9 | Carcinogenicity Study -Rat/Mouse |
| 10 | Combined Chronic Toxicity/Carcinogenicity Study-Rat/Mouse |
| 11 | Metabolism Study in Rats |
| 12 | Metabolism Study in Chicken |
| 13 | *Metabolism study in Cattle or Swine |
| 14 | Residue Study in Chicken |
| 15 | *Residue study in Cattle or Swine |
*Studies performed at strategic partners facility
