CMC & Formulation
Analytical method development and validation
Analytical chemistry testing and forced degradation study for Active Pharmaceutical Ingredients (APIs) and finished products
Stability studies supporting formulation feasibility, preclinical, and clinical studies
Raw material (e.g.: APIs and excipients) qualification
Formulation development for semi-solid and liquid dosage forms (e.g.: jelly, 70% Dex and injectable)
API and drug product specification development
Drug compatibility studies with excipients and packaging/closure materials
Characterization and Qualification
Assistance with material vendor qualification
Assistance with raw material selection in order to meet the regulatory requirements
Testing of polymer materials for their chemical properties (e.g.: polymer compositions, polymer molecule weight distributions , and reverse engineering)
Identification and analysis of extractables and leachables
Purification Development
Large biologics (e.g.: proteins, DNA, antibodies, and polypeptides)
Small molecules used as ingredients in pharmaceutical and dietary supplement products
Dietary Supplement
Analytical method development and validation
Purification and isolation of phytochemical/marker compound
Stability study design and testing
Raw material identification and qualification