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.