Global Regulatory Strategy

ICON’s Regulatory Consulting Solutions team has expertise in all aspects of drug, biologic, cell and gene therapies across a range of therapeutic indications.

We offer full-service development and regulatory consultancy, providing both strategic and operational support throughout the product development life cycle, covering preclinical/ analytical and clinical trial evaluation, marketing authorisation and post-approval maintenance.

The team works as part of the ICON clinical development organisation, as well as independently on standalone consulting projects for our clients. Our operational model is flexible, to adapt to individual client project requirements.

Key services

Strategic regulatory consulting:

Provide strategic guidance and operational execution across service lines and throughout the product lifecycle
In-country expertise and regulatory consulting: US (FDA), EU (EMA), Canada (HC), Korea (MFDS), China (NMPA), Japan (PMDA) and Australia (TGA)
Risk evaluation and mitigation strategy/ risk management plan consulting
Due diligence

Health authority interactions:

Act as global agency liaison ‘agent’ as needed (e.g. US and Canada)
Support global agency/ advisory meetings
Scientific advice

Regulatory expertise:

Program lead for US Investigational New Drug (IND) applications and maintenance, Canada Clinical Trial Applications and marketing authorisation applications
Expedited pathways (e.g. accelerated, priority, breakthrough, fast track, qualified infectious disease product designation, PRIME, innovative licensing and access pathway)
Orphan drug/ rare paediatric diseases designations
Gap analysis
Paediatric investigation/ study plan

ICON’s Regulatory Consulting Solutions team has expertise in all aspects of drug, biologic, cell and gene therapies across a range of therapeutic indications.

Key services

Strategic regulatory consulting:

Health authority interactions:

Regulatory expertise:

Regulatory writing/ review:

Post-marketing regulatory affairs support

In this section

Connect with us

Global Regulatory Strategy

ICON’s Regulatory Consulting Solutions team has expertise in all aspects of drug, biologic, cell and gene therapies across a range of therapeutic indications.

Key services

Strategic regulatory consulting:

Health authority interactions:

Regulatory expertise:

Regulatory writing/ review:

Post-marketing regulatory affairs support

In this section

Connect with us

ICON leads portfolio transition of growth and non-growth products

Regulatory Strategy in Clinical Development (EU)