Analytical data to support product development programmes and regulatory submissions.
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 analytical scientists generate data packages designed to support global regulatory requirements for IND, NDA and ANDA submissions, as applicable to the programme.
USFDA Approved Facility
with no 483s
Analytical Laboratory
supported by a range of analytical instrumentation
Stability Storage Facility
with walk-in stability rooms and 24/7 electronic security