JB Life Sciences
Expert CMC Problem Solving

JB Life Sciences provides CMC regulatory affairs consulting services including:
  • Gap analyses of CMC information available for IND, NDA and other types of regulatory submissions.
  • Preparation and review of pre-IND and other FDA meeting packages.
  • Preparation and review of CMC sections of INDs, NDAs and other submissions.
  • Responses to regulatory agency CMC questions.
  • Regulatory assessment of genotoxic and other types of impurities.
  • Drug substance and drug product specification guidance.
  • CMC expertise for regulatory submission project  teams.