CMC and Quality | ICON plc

The ICON CMC and Quality Team provides robust CMC strategies, executed by industry-leading experts.

Our team is adept at designing and delivering CMC programs to take candidates from discovery to early clinical trials, through scale up and optimisation, to process validation and registration. All with hands-on resources to manage implementation.

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

The team’s approach is flexible and collaborative, whether providing a single piece of strategic technical consultancy, or joining your team for the design and implementation of your CMC strategy.

Key services

Operational execution of core services and/ or across service lines:

Health Canada Drug Establishment License and Importer of Record services
Genetically Modified Organism applications
Quality services
Audit services

Writing and review of CMC packages for all pre- and post-approval submissions (small and large molecules including cell and gene therapies):

Change controls and impact assessments
CMC component review, gap analysis and due diligence for Clinical Trail Applications and Marketing Authorisation Applications
CMC authored documents for Investigational New Drug Applications, Biologics License Application, New Drug Applications and Marketing Authorisation Applications

Development strategy for small molecules:

Technology transfer
Active pharmaceutical ingredient development
Drug product development

Development strategy for biologics:

Process development (quality target product profile, certificate of analysis and certificate of pharmaceutical product risk assessment) and manufacturing
Analytical method development
Process validation
Life cycle management

The ICON CMC and Quality Team provides robust CMC strategies, executed by industry-leading experts.

Key services

Operational execution of core services and/ or across service lines:

Writing and review of CMC packages for all pre- and post-approval submissions (small and large molecules including cell and gene therapies):

Development strategy for small molecules:

Development strategy for biologics:

In this section

Connect with us

Chemistry, Manufacturing and Controls (CMC) and Quality

The ICON CMC and Quality Team provides robust CMC strategies, executed by industry-leading experts.

Key services

Operational execution of core services and/ or across service lines:

Writing and review of CMC packages for all pre- and post-approval submissions (small and large molecules including cell and gene therapies):

Development strategy for small molecules:

Development strategy for biologics:

In this section

Connect with us

Accelerating ATMP and CGT: The importance of Regulatory CMC expertise in efficient biologics development

Regulatory CMC: Enhancing Biologics Development. Preventing delays and accelerating the progression of these critical therapies

Regulatory CMC

Seamless transition and lifecycle management for 50+ marketed products

Application of project management strategy to postapproval CMC submissions

CMC in Drug Development