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.
21 CFR Part 11
Compliant Systems
maintained under cGMP conditions
USFDA
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
