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

Aragen’s analytical solutions provides a holistic approach to developability and formulation studies, including stand-alone biophysical, biochemical and mass spectrometry characterization, to help clients understand and control critical quality attributes. Our experienced analytical scientists ensure data generated supports global regulatory requirements for IND/NDA/ANDA submissions.

50+ Analytical
Scientists

with diverse skillsets and experience

21 CFR Part 11
Compliant Systems

maintained under cGMP conditions

USFDA
Approved Facility

with no 483s

10,000 sq ft
Analytical Laboratory

with industry leading range of instrumentation

60,000 L Stability
Storage Facility

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