IND-Enabling Studies
Adgyl Lifesciences offers a comprehensive suite of IND-enabling safety assessment services, including regulatory toxicology, CMC support, and integrated Pharm‑Tox packages. We have successfully supported the preparation and submission of 200+ IND packages to global regulatory authorities, including the USFDA, EMA, MHRA, TGA, Health Canada, DCGI, ANSM, and others.
Our integrated preclinical development capabilities encompass:
- Analytical support (dose formulation)
- Bioanalytical method development and validation
- Genotoxicity
- Safety pharmacology
- Toxicology studies
- We deliver end-to-end IND-enabling support, ensuring all studies and data are aligned with global regulatory expectations.
Integrated IND-Enabling Capabilities
We provide GLP-compliant safety pharmacology and repeat-dose toxicology studies in both rodent and non-rodent species. Our programs are scientifically designed to generate high-quality, regulatory-compliant data that supports confident progression into first-in-human (FIH) clinical trials.
Core IND-Enabling Study Portfolio
- Ames test
- In vitro chromosomal aberration test in Human Peripheral Blood Lymphocytes (HPBL)
- In vivo micronucleus test (mice/rats)
- In vivo COMET assay
- hERG assay
- Pulmonary function assessment (rats)
- Modified Irwin Test / Functional Observation Battery (FOB) in rats
- Cardiovascular (CVS) function assessment in telemetered dogs
Rodents (Rat):
- Maximum Tolerated Dose (MTD) study
- epeat-dose Dose Range Finding (DRF) study
- 28-Day repeat-dose toxicity study
Non-Rodents (Dog):
- Maximum Tolerated Dose (MTD) study
- Repeat-dose Dose Range Finding (DRF) study
- 28-Day repeat-dose toxicity study
Scientific Partnership
Partnering for Scientific Excellence
At Adgyl Lifesciences, we go beyond being a service provider—we act as a trusted scientific partner throughout your development journey.
Scientifically rigorous, reproducible, and timely study execution
High-quality data generation aligned with global regulatory standards
Seamless end-to-end support, from study design to data interpretation
Connect with our expert team to discuss how we can support your IND-enabling program and accelerate your development timeline.
what people ask
Frequently Asked Questions
Can you support early‑stage decision‑making before GLP studies?
Yes. We offer non-GLP exploratory studies, including:
- Mini Ames
- Early hERG screening
- Dose range-finding studies
- Cardiovascular screening in telemetered dogs
These studies help identify potential risks early and guide the design of definitive GLP programs.
What genotoxicity studies do you offer for IND submissions?
We provide a full suite of GLP-compliant genotoxicity studies, including:
- Ames test
- In vitro chromosomal aberration (HPBL)
- In vivo micronucleus test
- COMET assay
All studies are conducted in alignment with global regulatory expectations for IND submissions.
Can you perform both rodent and non‑rodent toxicology studies?
Absolutely. We conduct GLP toxicology studies in both rats and dogs, including:
- MTD studies
- Dose range-finding studies
- 28-day repeat-dose toxicity studies
These are designed to support IND-enabling packages.
How do you support regulatory interactions and submissions?
In addition to study conduct, we support:
- Study planning and design
- Data interpretation
- Preparation of IND-ready reports
All deliverables are aligned with global regulatory expectations to facilitate submission readiness.
How can I determine which studies are needed for my program?
Our scientific team collaborates closely with clients to understand:
- Molecule characteristics
- Target indication
- Development stage
Based on this, we design a fit-for-purpose IND-enabling strategy that balances scientific rigor, timelines, and regulatory requirements.
