...working with Altasciences has been excellent, from both a bioanalytical, and a bioavailability study perspective. We are really impressed with their planning and execution abilities – I would not consider another provider for future work.
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The U.S. FDA issued Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry to provide its perspective on (and recommendations) for the CMC (chemistry, manufacturing, and control), nonclinical, and clinical aspects related to such vaccines.
Sep 22, 2020
As you work towards a successful New Drug Application (NDA) submission, there are many considerations that must be taken into account, specifically for CNS-active drugs.
Safety assessments for both small and large molecules
Clinical pharmacology trials from first-in-human to end of Phase II
From formulation development, phase I through commercial manufacturing, and ICH stability testing
As part of our full service offering or as standalone solutions
Comprehensive CRO services to support clinical and preclinical studies