Non-Clinical Animal Safety Studies & CMC for Veterinary Pharmaceuticals

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
1Target Animal Safety Chicken
2*Target Animal Safety Cattle, Dog & Swine
3Genotoxicity Testing – Ames, In Vitro and In Vivo Chromosomal Aberration
4Repeated Dose (28 to 90- Day) Toxicity Study in Rat
5Repeat-Dose (28 to 90-Day) Toxicity Study in Dog/ Swine
6Two-Generation Reproduction Toxicity Study in Rat
7Developmental Toxicity Testing in Rat – (Rabbit: Optional)
8Chronic Toxicity Study Rat – (Dog: Optional)
9Carcinogenicity Study -Rat/Mouse
10Combined Chronic Toxicity/Carcinogenicity Study-Rat/Mouse
11Metabolism Study in Rats
12Metabolism Study in Chicken
13*Metabolism study in Cattle or Swine
14Residue Study in Chicken
15*Residue study in Cattle or Swine

*Studies performed at strategic partners facility