At Aragen, we deliver comprehensive IND-enabling toxicology solutions designed to accelerate your path to first-in-human clinical trials. Our integrated preclinical engine brings together toxicology, ADME, pharmacology, bioanalysis, and quality assurance in one seamless flow-reducing development time without compromising scientific quality or regulatory confidence.
From first toxicology study to IND submission in as little as 9 months – driven by optimized timelines, parallelized workflows, and proactive risk management.
Subject matter experts tailor study designs to your asset type – whether small molecules, biologics, or emerging modalities – ensuring fit-for-purpose strategies from the outset.
Your program is led by DABT-certified toxicologists and histopathology experts, providing deep mechanistic insight and regulatory foresight.
An aligned toxicology, ADME, pharmacology, and independent QAU team operating across India and the USA troubleshoots issues rapidly and strengthens your IND package in real time.
Our LC-MS/MS and broad bioanalytical platform delivers reliable quantification in complex matrices, evaluating exposure and toxicokinetic data for regulators.
Benefit from centrally managed large animal programs with access to premier facilities in the US, Europe, and Asia, all coordinated through a single accountable partner.
A dedicated Chief Scientific Officer, experienced program leaders, and proactive project managers guide your asset seamlessly from discovery through IND and beyond.
Our global supply chain and logistics management keep your studies on schedule with seamless movement of test articles and samples across regions for US and EU submissions.
We help biotech and pharmaceutical developers generate regulatory-aligned nonclinical safety data that supports high-impact IND submissions. Our services span exploratory studies, full nonclinical safety assessment programs, and dossier support – ensuring alignment with global regulatory expectations, including US FDA, EMA, and other international agencies.
Exploratory & Lead-Selection Studies
Test Species
Routes of Exposure
Study Types Offered
Safety Pharmacology
Genetic Toxicology
Capabilities
Assay Platforms
Advanced Analytics
Modalities
Regulatory Dossier Support
| Studies/Weeks | 1-4 | 5-8 | 9-12 | 13-16 | 17-20 | 21-24 | 25-28 | 29-32 | 33-36 | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analytics | |||||||||||||||||||||||||||||||||||||||||||
| DF-method development & validation | 4 | ||||||||||||||||||||||||||||||||||||||||||
| BA method development & validation – Rat | 5 | ||||||||||||||||||||||||||||||||||||||||||
| BA method development & validation-Non-rodent | 5 | ||||||||||||||||||||||||||||||||||||||||||
| General Tox | |||||||||||||||||||||||||||||||||||||||||||
| MTD & 7-10 days repeat dose DRF with TK in Rat | 5 | ||||||||||||||||||||||||||||||||||||||||||
| MTD & 7-10 days repeat dose DRF with TK in Non-rodent | 8 | ||||||||||||||||||||||||||||||||||||||||||
| 4 Week in Rat with 2 or 4 Week recovery – Rat | 18 | ||||||||||||||||||||||||||||||||||||||||||
| 4 Week in Non-rodent with 2 or 4 Week recovery Non-rodent | 20 | ||||||||||||||||||||||||||||||||||||||||||
| Safety Pharmacology | |||||||||||||||||||||||||||||||||||||||||||
| CNS in Rat | 6 | ||||||||||||||||||||||||||||||||||||||||||
| RESP in Rat | 6 | ||||||||||||||||||||||||||||||||||||||||||
| HERG-patch clamp. | 4 | ||||||||||||||||||||||||||||||||||||||||||
| CVS – Dog telemetry | 10 | ||||||||||||||||||||||||||||||||||||||||||
| Mutagenicity | |||||||||||||||||||||||||||||||||||||||||||
| AMES test | 4 | ||||||||||||||||||||||||||||||||||||||||||
| In vitro CA or MNT | 8 | ||||||||||||||||||||||||||||||||||||||||||
This timeline represents a comprehensive integrated approach covering analytical method development, repeat-dose toxicology with toxicokinetics, safety pharmacology, and genetic toxicology – all optimized for a 9-month IND-enabling submission.
| Studies/Weeks | 1-4 | 5-8 | 9-12 | 13-16 | 17-20 | 21-24 | 25-28 | 29-32 | 33-36 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BA method development-Rat | 4 | |||||||||||||||||||||||||||||||||||
| BA method validation – Rat | 6 | |||||||||||||||||||||||||||||||||||
| BA partial method validation – NHP | 8 | |||||||||||||||||||||||||||||||||||
| DF method development | 2 | |||||||||||||||||||||||||||||||||||
| DF method validation | 3 | |||||||||||||||||||||||||||||||||||
| Immunogenicity: method development in Rat | 8 | |||||||||||||||||||||||||||||||||||
| Immunogenicity: method validation in Rat | 8 | |||||||||||||||||||||||||||||||||||
| Immunogenicity: method development in NHP | 8 | |||||||||||||||||||||||||||||||||||
| Immunogenicity: method validation in NHP | 8 | |||||||||||||||||||||||||||||||||||
| Single dose & DRF in Rat* | 8 | |||||||||||||||||||||||||||||||||||
| Single dose & DRF in NHP* | 12 | |||||||||||||||||||||||||||||||||||
| 4 Week in Rat with 2 or 4 Week recovery – Rat | 18 | |||||||||||||||||||||||||||||||||||
| 4 Week in NHP with 2 or 4 Week recovery – NHP | 20 | |||||||||||||||||||||||||||||||||||
This timeline reflects pivotal studies customized for biologic entities, including immunogenicity method development, single-dose and DRF studies across relevant species, and regulatory-aligned pivotal toxicology.
High-quality data generation supports compliance with global registration requirements and enables effective internal decision-making throughout molecule development.
At Aragen, we don’t just conduct studies-we engineer IND-enabling pathways that are scientifically rigorous, regulator-ready, and execution-driven. Whether you’re advancing a new chemical entity or a novel biologic, our full spectrum of toxicology capabilities ensures you progress toward the clinic with certainty and speed.
