Veterinary Pharmaceuticals
End-to-end research and development solutions supporting animal health and veterinary drug development.
Industry Focus
Integrated Research & Safety Evaluation Services for Veterinary Pharmaceuticals
Adgyl Lifesciences provides comprehensive services of data generation for the registration of veterinary pharmaceuticals including medicines/drugs, vaccines and biologics in regulated markets as per the Veterinary International Conference on Harmonization (VICH) requirements.
We support the animal health market by conducting safety studies for innovative veterinary drugs and vaccines in food-producing and companion animals, generating data for Investigational New Animal Drug (INAD) and New Animal Drug Application (NADA) submissions, along with GMP-compliant CDMO services for clinical APIs and GLP bioanalysis of clinical samples.
Core capabilities
- Target animal safety chicken
- *Target animal safety cattle, dog & swine
- Genotoxicity testing – Ames, in vitro and in vivo chromosomal aberration
- Repeated dose (28 to 90 Day) toxicity study in rat
- Repeat dose (28 to 90 Day) toxicity study in dog/swine
- Two-generation reproduction toxicity study in rat
- Developmental toxicity testing in rat – (rabbit: optional)
- Chronic toxicity study rat – (dog: optional)
- Carcinogenicity study -rat/mouse
- Combined chronic toxicity/carcinogenicity study-rat/mouse
- Metabolism study in rats
- Metabolism study in chicken
- *Metabolism study in cattle or swine
- Residue study in chicken
- *Residue study in cattle or swine
*Studies performed at strategic partners facility
Regulatory Credentials
Regulatory & Quality Credentials
- First GLP-Accredited in India
We are the first GLP-accredited laboratory in India and has been successfully audited by the USFDA (2012 and 2016) for GLP studies submitted as part of IND/NDA packages.
- Certified Quality Standards
Our vivarium was the first to have been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) since 2001 and all animal study protocols are reviewed and approved by the Institutional Animal Ethics Committee (IAEC), which is equivalent to Institutional Animal Care and Use Committee (IACUC).
- Regulatory-Ready SEND Data
We deliver validated, submission ready SEND datasets delivered via the FDA-required Submit™ platform
Proven Experience
Established Expertise
With over 1100 clients and 30+ years of experience in conducting drug development studies. We are proud of our strong track record of regulatory submissions and robust historical control data and therefore feels confident in developing and thoroughly assessing the safety profile of your molecules. As an extension of your team, our scientists and technicians will help enable and expedite your research goals, ensuring that your preclinical drug development program provides quality data for key decision-making.
Clients
Years Experience
Global Regulatory Submissions
Investigational New Drug
(IND) packages submitted
- USFDA (US)
- EMA (Europe)
- MHRA (UK)
Global Regulatory Submissions
Investigational New Drug (IND) packages submitted
- EMA (Europe)
- MHRA (UK)
- USFDA (US)
what people ask
Frequently Asked Questions
What services do you offer for veterinary pharmaceuticals?
We provide end-to-end research, safety evaluation, and data generation services for veterinary drug development.
What types of veterinary products do you support?
We support medicines/drugs, vaccines, and biologics for animal health.
Do your studies comply with regulatory requirements?
Yes, all services are aligned with VICH (Veterinary International Conference on Harmonisation) requirements.
Can you support regulatory submissions?
Yes, we generate data for INAD and NADA submissions.
Do you conduct safety studies in target animals?
Yes, we perform target animal safety studies in species such as chicken, cattle, dog, and swine.
