In vitro Studies
Adgyl Lifesciences offers full range of Safety Assessment Regulatory Tox, IND enabling CMC and PharmTox packages. It also offers both cGMP material for your early clinical development, late clinical development (for niche molecules).
Adgyl Lifesciences offers full range of Safety Assessment Regulatory Tox, IND enabling CMC and PharmTox packages. It also offers both cGMP material for your early clinical development, late clinical development (for niche molecules).
- Studies comply with current international guidelines (ICH, US-FDA, EMA, OECD) and are performed in compliance with GLP to ensure worldwide acceptability
- OECD-accredited Test Facility
- CMC and Pharm-tox integration for accelerated submission
- Experienced study directors and leadership team to guide sponsors appropriately for developing study plans
Adgyl Lifesciences offers following IND enabling studies:
Exploratory studies (Non-GLP)
- Mini Ames
- Mini hERG (hERG screening)
- Dose range finding studies
- CVS function screening in telemetered dogs
Genotoxicity (GLP)
- Ames Test
-
In vitro Chromosomal aberration test in Human
Peripheral Blood Lymphocytes (MUT CHAB/HPBL) - Micronucleus test (MNT) in Mice/Rats
Process Hazard Analysis
- hERG assay
- Modified Irwin Test/Functional Observation Battery in rats (FOB-Rats)
- Pulmonary functions(Rats)
- CVS function assessment using telemetered dogs
Toxicology studies (GLP)
- Maximum Tolerated Dose (MTD) followed by 10 day repeat dose range finding(DRF) in Rat
- 28-Day Repeat dose toxicity study in Rat
- Maximum Tolerated Dose (MTD) followed by 10 day repeat dose range finding(DRF) in Dog
- 28 Day Repeat dose toxicity study Dog
Scientific Partnership
Partnering for Scientific Excellence
Eurofins Advinus and our partner laboratory Adgyl Lifesciences work closely together to ensure.
Scientifically rigorous, reproducible, and timely study execution
High-quality data generation aligned with regulatory & scientific requirements
End-to-end support from model selection to data interpretation
Connect with our expert team today to discuss how we can support your in vivo pharmacology and imaging needs.
what people ask
Frequently Asked Questions
What stage of drug development do your services support?
Our services support multiple stages of drug discovery and development, from early exploratory research to IND-enabling and regulatory-compliant non-clinical studies.
Are your studies conducted under GLP compliance?
Our services support multiple stages of drug discovery and development, from early exploratory research to IND-enabling and regulatory-compliant non-clinical studies.
Can services be customized based on specific program needs?
Our services support multiple stages of drug discovery and development, from early exploratory research to IND-enabling and regulatory-compliant non-clinical studies.
How do you ensure data quality and regulatory acceptance?
Our services support multiple stages of drug discovery and development, from early exploratory research to IND-enabling and regulatory-compliant non-clinical studies.
How do sponsors typically engage with your scientific teams?
Our services support multiple stages of drug discovery and development, from early exploratory research to IND-enabling and regulatory-compliant non-clinical studies.
