CMC Consultancy – Small Molecules


ICON provides integrated, global CMC solutions, built from our expertise in chemistry, pre-formulation and pharmaceutical development. Our comprehensive services support clients in all phases of development, to design and deliver CMC packages from candidate selection through proof-of-concept to marketing approval, that meet client timelines and budgets.

Through knowledge of current technical, regulatory and cGMP requirements, our team addresses complexities at the interfaces between CMC, nonclinical and clinical development. Clients avoid unnecessary product delays to transition seamlessly through each discipline and ensure lead candidates move smoothly through development and meet project milestones.

Projects can be delivered as standalone consulting engagements or as development and implementation of a more detailed CMC strategy, covering the following areas:

DEVELOPMENT STRATEGY

  • Designed in partnership with the client and integrated with other functions
  • Pragmatic solutions
  • Managed through supplier network
  • Regulatory CMC strategy

PRE-FORMULATION

  • Candidate selection
  • Polymorphism studies
  • Salt selection studies
  • Co-crystal evaluation
  • Formulations for pre-clinical studies

API DEVELOPMENT

  • Route development
  • Analytical development
  • Manufacturing
  • Quality control
  • Stability testing
  • Change management
  • Troubleshooting

DRUG PRODUCT DEVELOPMENT

  • Clinical dosage form development
  • Analytical development
  • Manufacture of clinical trials material
  • Clinical packaging and labelling
  • Quality control
  • Stability testing
  • Change management
  • Trouble shooting