Clinical Trial Material
Our experienced development scientists formulate and produce required quantities of clinical trial materials for all stages of your project. From simplified dosage forms in the earliest clinical stages to phase III batches of your final product. This enables us to scale your product from early development through phase III and ultimately to commercial manufacturing at Galenica or at a contract manufacturer of choice.
Clinical trial manufacturing and packaging services include:
- • EU and U.S. standards
- • Phase I, II and III clinical supplies
- • Full CTM formulation, manufacturing, packaging and release testing
- • IND (Investigational New Drug Application) and IMPD (Investigational Medicinal Product Dossier) support documentation
- • Qualified Person (QP) release of CTM