CMC support for programmes moving through clinical development, process validation and to commercialisation

JKonsult provides pragmatic and phase-appropriate scientific, technical, and strategic advice for the development of new chemical entities that are in the preclinical and early clinical stages of development through to later phases of clinical development and supporting commercial launch.  This includes activities such as:

  • assessing risks to quality from (potential) mutagenic impurities to enable design and development of phase-appropriate control strategies
  • assessing risks to quality to enable design of fate and purge studies and hence development of control strategies
  • assessing, evaluating and justifying the nomination of regulatory starting materials
  • evaluating processes to design critical process parameters assessments
  • supporting process performance qualification (process validation)