ICON’s team of experienced and dedicated Regulatory Affairs Professionals provide expert services to the pharmaceutical and biotechnology industries, including regulatory strategy development, health authority meetings and interactions, clinical trial applications, drug and medical device submissions, expedited and collaborative reviews (e.g., Priority Review, Conditional Approvals, Project Orbis, ACCESS, Health Canada/HTA joint review), expert advisory committees, due diligence assessments and more. By providing strategic and informed regulatory guidance, we help secure timely, optimal, and competitive approvals. Additionally, we provide ongoing support to ensure compliance and to maximise opportunities across the product lifecycle.

ICON also offers Market Access, Medical Information, Pharmacovigilance, Quality Control and Drug Establishment License (DEL) services.