JB Life Sciences
Expert CMC Problem Solving

JB Life Sciences provides CMC consulting services including:
  • Contractor selection for CMC projects.
  • Requests for Proposals (RFPs) and selection criteria for outsourced projects.
  • Management of drug substance development and manufacture.
  • Coordination of formulation development projects.
  • Management of drug product and Clinical Trial Material (CTM) manufacture.
  • Management of analytical chemistry and stability studies for drug substances and drug products. 

  • Management of genotoxic impurity studies per new guidance.
  • Review and approval of  batch records and GMP documentation.
  • Investigations of OOS results and batch failures.
  • CMC expertise for pharmaceutical development project teams.