Analytical data to support product development programmes and regulatory submissions.
Aragen Life Sciences provides phase-appropriate analytical development for small molecules. Our scientists develop and validate methods and generate data packages that support IND (investigational new drug), NDA (new drug application) and ANDA (abbreviated new drug application) submissions, as applicable to each program.
Methods are developed iteratively and in parallel with process and formulation work, so validated methods are ready as the drug candidate progresses.
USFDA Approved Facility
Zero Form 483s in the last two USFDA inspections (2019, 2025).
Analytical Laboratory
Analytical laboratories with a range of instruments for small molecule methods
Stability Storage Facility
Walk-in stability rooms with 24/7 electronic security. All ICH (International Council for Harmonisation) stability conditions.
Frequently Asked Questions (FAQs)
A stability-indicating method measures the active ingredient and can detect changes or degradation over time
IND, NDA and ANDA submissions, as applicable to the program.
Chemicals that can migrate from packaging or process components into a drug product. Studies identify and assess them.
