Your Trusted

CMC Partner

Experience. quality. speed.

YuChem Consulting is your trusted business partner to accomplish all your CMC delivery goals in a timely and cost effective manner.

 

 

our services

cmc strategies

  • Accelerated CMC timeline to enable IND and FIH studies
  • Optimal pathway from IND to NDA
  • Strategic selection of CRO/CMO partners
  • Cross-functional teamwork

drug substance

  • IND-enabling tox batch and initial GMP batch delivery
  • Design and optimization of synthetic route
  • GMP manufacturing from Phase I to post-approval

drug product

  • Preformulation studies (salt, polymorph, solubility, etc)
  • Early phase formulation selection and development
  • Powder-in-capsules, capsules, tablets and beyond

 

 

additional areas

  • Expert in genotoxic impurity (GTI) control and ICH M7
  • Phase-appropriate analytical dev and validation strategies
  • Authoring of IND, IMPD, and other CMC regulatory documents

a winning CMc team

Contact us today to discuss how YuChem can help your company advance your pipeline, achieve ambitious business goals, and stand out from the competition.