NDA Filing
Adgyl Lifesciences offers a comprehensive portfolio of toxicology studies designed to support New Drug Application (NDA) submissions in a scientifically robust and cost-effective manner. Our integrated toxicology programs are aligned with global regulatory expectations and are structured to generate high-quality safety data that supports informed development and regulatory decision-making.
We conduct repeat-dose toxicology studies with integrated toxicokinetics across rodent and non-rodent species, including 90-day, 6 to 12-month, and 9-month study durations. Our capabilities span mice, rats, Beagle dogs, minipigs, and non-human primates*, supporting thorough evaluation of systemic exposure, target organ toxicity, and safety margins.
Non-clinical Studies Directed towards NDA Filing
Our services also include carcinogenicity studies, developmental and reproductive toxicology (DART) programs , and juvenile toxicology studies in rats. For non-human primate studies, in-life phases are conducted at qualified partner facilities, with all subsequent evaluations performed at Adgyl to ensure data consistency and regulatory confidence.
Key services include
- 90-Day repeat dose toxicology studies with toxicokinetics in rodents and non-rodents
- 6 to 12 Month repeat dose toxicology studies with toxicokinetics in mice/rats
- 9-Month repeat dose toxicology studies with toxicokinetics in non-rodents (Beagle dog/Minipigs/NHP*)
- 6-Month carcinogenicity study in Transgenic rasH2 mice with toxicokinetics
- Fertility and early embryonic development to implantation (FEED) studies in mice /rats
- Embryo fetal development (EFD) toxicity studies in mice/rats/rabbits
- Pre-natal and post-natal developmental (PPND) studies in rats
- Juvenile toxicology studies in rats
- Carcinogenicity studies in mice/rats
SCIENTIFIC PARTNERSHIP
Partnering for Scientific Excellence
Adgyl Lifesciences is committed to ensure
Scientifically rigorous, reproducible and timely study execution.
High‑quality data generation aligned with scientific & regulatory requirements
Seamless end‑to‑end support spanning study design, execution, and data interpretation.
Connect with our expert team today to discuss how we can support your NDA filing.
what people ask
Frequently Asked Questions
Can you design a complete toxicology strategy for NDA submission?
Yes. We support end‑to‑end toxicology strategy development, including selection of appropriate repeat‑dose, reproductive/developmental, carcinogenicity, and juvenile studies, ensuring alignment with regulatory guidelines and clinical plans.
Are your repeat‑dose studies suitable for chronic clinical indications?
Yes. Our long‑term repeat‑dose studies, including 6‑ to 12‑month rodent and 9‑month non‑rodent studies with toxicokinetics, are well‑suited for chronic and long‑duration clinical indications.
How do toxicokinetic assessments support regulatory submissions?
Integrated toxicokinetic assessments help establish systemic exposure, support dose justification, correlate exposure with toxicological findings, and define safety margins—key elements for regulatory review and NDA acceptance.
Do you offer accelerated alternatives to traditional carcinogenicity studies?
Yes. We conduct accelerated 6‑month carcinogenicity studies in transgenic rasH2 mice with toxicokinetics, providing an efficient alternative to conventional long‑term carcinogenicity studies when scientifically appropriate.
Are study designs flexible across therapeutic areas?
Yes. Study designs can be tailored based on therapeutic indication, dosing regimen, duration of clinical exposure, and regulatory guidance, ensuring scientific relevance and efficiency.
