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
USFDA Approved Facility
with no 483s
with industry leading range of instrumentation
Stability Storage Facility
with walk-in stability rooms and 24/7 electronic security
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