Offered through our partner laboratory, Adgyl Lifesciences
Eurofins Advinus through the partner laboratory Adgyl Lifesciences, delivers comprehensive regulatory and exploratory toxicology services designed to meet the highest global standards. With over 30 years of scientific and regulatory expertise, Adgyl Lifesciences offers GLP-compliant studies tailored to support safety assessment needs across a diverse range of industries, including:
- Pharmaceuticals and Biotech
- Biologics and Biosimilars
- Vaccines
- Agrochemicals
- Industrial Chemicals and Dyes
- Medical Devices
- Nutraceuticals and Herbal Products
- Cosmetics
- Veterinary Pharmaceuticals
Science. Compliance. Speed. Backed by Adgyl Lifesciences
- USFDA-audited GLP facility (twice); recognized by leading global authorities such as EMA, MHRA, TGA, Health Canada, and DCGI
- 120+ scientists, including 17 DABT/ERT-certified study directors
- Successfully executed 300+ IND/NDA studies and 30,000+ regulatory studies
- Specialized in 600+ reproductive and developmental toxicology studies
- Home to one of South Asia’s largest AAALAC-accredited vivariums
- All studies undergo ethical review by IAEC, in alignment with IACUC standards
- Equipped with advanced SEND-compliant systems and validated digital pathology platforms
- Proven capabilities in complex study designs—chronic, reproductive, carcinogenicity, juvenile toxicity, and transgenic models
Meet the Scientific Leaders
At the core of our toxicology services is a globally respected team of scientific experts:
- 35+ Study Directors with an average experience of 15+ years
- 9 DABT-certified toxicologists
- 8 Veterinary Pathologists, mentored by a 30-year industry veteran
- Internationally peer-reviewed pathology data (US, Europe, Japan, Israel)
Proven Success Stories
- Submission of 300+ IND/NDA packages to global regulatory agencies
- Conducted 28-day and long-term BID dosing studies for novel therapeutics
- Achieved 100% survivability in a 6-month Tg rasH2 mouse carcinogenicity study (for USFDA)
- Designed and completed 25+ impurity qualification studies, accepted worldwide
Let’s Accelerate Your Regulatory Journey
Whether you’re advancing a new chemical entity, biologic, medical device, or agrochemical, we provides timely, high-quality toxicology studies to help you meet regulatory milestones with confidence.
Frequently Asked Questions (FAQ’s)
GLP (Good Laboratory Practice) ensures that non-clinical safety studies are conducted with integrity, transparency, and reproducibility. Regulatory bodies like the USFDA, EMA, and TGA require GLP-compliant data for approvals and evaluations.
All animal studies are reviewed and approved by the Institutional Animal Ethics Committee (IAEC)—aligned with international IACUC standards. Additionally, our facility is AAALAC-accredited, ensuring best-in-class animal care.
We offer a wide range of studies, including acute, sub-chronic, chronic, reproductive, developmental, carcinogenicity, genotoxicity, and juvenile toxicity—all tailored to meet your program’s regulatory goals.
Absolutely. We’ve supported 300+ IND/NDA submissions globally, including to the USFDA, EMA, TGA, and others, with fully compliant study packages.
Digital pathology enables high-resolution image sharing and expert global peer reviews. SEND (Standard for Exchange of Nonclinical Data) ensures your study data is seamlessly submitted and accepted by regulatory authorities like the USFDA.
