Analytical Method Development, Stability and Testing

Capsugel provides full analytical development and validation in support of formulations for clinical trial materials and commercial products. We have analytical staff located at each of our integrated product development sites. From our fully GLP-compliant analytical development laboratories, our experienced teams of analysts provide:

Early Development Services Late-Stage Development Services
API handling protocols Manufacturing process development
API characterization QC methods
Excipient compatibility testing and selection Analytical method optimization, qualification and validation
Pre-formulation and formulation development Cleaning methods / verifications
Analytical method development and qualification  Product release and stability testing
Release and stability testing  Clinical trial material manufacture 
Clinical trial material manufacturing QC / QP release
IND / IMPD dossier support  Regulatory dossier support