Complete CMC programme strategy, design and implementation

We apply scientific excellence and regulatory expertise every step of the way. We work with clients on active ingredients, formulations, manufacturing process and controls, and specifications for new chemical and biological entities and new formulations of approved products.

ICON supports all phases of development with proven technical expertise in the design of biologics and small molecule CMC strategy and hands-on resources to manage its implementation. Our team is adept at designing and delivering CMC programs to take candidates from discovery to early clinical trials, through scale up and optimization, to process validation and registration.

The ICON CMC team has extensive industry experience in the development of biologics and small molecules from product concept through to post approval changes  The team’s  approach is flexible and collaborative, whether providing a single piece of strategic technical consultancy, or joining your project team for the design and implementation of your CMC strategy.

Clients rely on our independent and objective analysis to ensure that projects meet the required technical and quality objectives, on time and within budget. We work with clients to define the most streamlined CMC program for each product, to identify issues as they arise, manage the unexpected, and keep the project on track. We provide comprehensive consultancy services for both biologics and small molecules. 

CMC consultancy – biologics

  • Development strategy
  • Process development and manufacturing
  • Process validation
  • Analytical development

CMC consultancy – small molecules

  • Development strategy
  • API development
  • Drug product development 
  • Analytical development