Reliable and reproducible analytical data to support speedy filing for regulatory approval.

Aragen analytical solutions are phase-appropriate and executed in parallel. Our approach is iterative, focusing on continuous improvement so that the developed and validated methods support the progress of customer drug candidates. Our experienced analytical scientists ensure data generated supports global regulatory requirements for IND/NDA/ANDA submissions.

21 CFR Part 11
Compliant Systems

maintained under cGMP conditions

Approved Facility

with no 483s

Analytical Laboratory

with industry leading range of instrumentation

Stability Storage Facility

with walk-in stability rooms and 24/7 electronic security