Chemistry, Manufacturing and Controls (CMC)
SRI’s dosage form manufacturing facilities are designed to provide you with a single, high-quality resource for the manufacture and packaging of oral, topical, and parenteral products for nonclinical and clinical studies. These activities are supported by our Quality Control and Quality Assurance Units which inspect, test, and release the products in full compliance with the FDA GLP and cGMP regulations and international regulatory agencies.
Our R&D, GLP, and cGMP facilities and equipment are designed to support early phase development. The low volume batches needed for safety evaluations and early clinical trials present unique challenges, and we are ready to work with you to overcome limited bulk drug supplies and tight turnaround times.
Our extensive collection of manufacturing equipment provides the capabilities needed to produce R&D, pilot, and clinical-scale batch sizes, including:
Mixing and Blending
Solid Dosage Forms
Innovative Science Overcomes Formulation Challenges
Partnering to Advance Therapy for Radiation Exposure
Through a broad range of services for the National Institutes of Health, SRI is accelerating preclinical development of potential therapies for diseases that affect millions of people.
SRI is conducting preclinical development of treatments for diseases such as tuberculosis, West Nile virus, hepatitis, and biodefense pathogens and toxins.