IND Enabling 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).

We have successfully submitted 90+ IND packages for submission to regulatory agencies across the world including USEPA, Mexico, Brazil, USFDA, ICH, MHA and EMA. Adgyl is a GLP and AAALAC-accredited lab and was successfully audited by the USFDA (2012 and 2016) for GLP studies submitted as part of IND packages.

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

Safety Pharmacology (GLP)

hERG assay
Pulmonary functions(Rats)
Modified Irwin Test/Functional Observation Battery in rats (FOB-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
Maximum Tolerated Dose (MTD) followed by 10 day repeat dose range finding(DRF) in Dog
28-Day Repeat dose toxicity study in Rat
28 Day Repeat dose toxicity study Dog