R&D Services: CMC
Chemistry Manufacturing Controls (CMC) Services
The process of taking a new chemical entity (NCE) from discovery to a drug substance and ultimately a large-scale manufacturable drug product is a key component in pharmaceuticals. From early-stage pilot synthesis to preformulation characterization and analytical method development, Constitution Laboratories offers a suite of services to meet your CMC needs.
- Pilot scale synthetic chemistry
- New chemical entity physiochemical characterization directed toward drug formulation.
- Pre-Formulation studies
- Forced degradation and stability indicating methods
- GLP analytical (method development and validation)
- Stability studies
Synthesis Suite
Constitution Laboratories maintains a suite of industrial fume hoods and preparative equipment in which to conduct pilot synthesis development. These initial lots are instrumental in the initial stages of drug discovery and development.