Regulatory consulting case studies
Delivering strategic regulatory consulting across the product life cycle
Encompassing over 1,000 experts across more than 90 locations we deliver customised, end-to-end regulatory solutions tailored to your needs.
CMC and local regulatory expertise deliver timely anti-cancer drug approval
An international biopharmaceutical company based in the EU contracted ICON to support a new biologic drug application in Canada for an anti-cancer therapy for diffuse large B-cell lymphoma (DLBCL) under advance consideration.
ICON leads portfolio transition of growth & non-growth products
A sponsor hired ICON to perform global regulatory affairs services (e.g., regional leads, CMC, labelling, publishing, and
submission management) for a recently acquired portfolio of registered products.
submission management) for a recently acquired portfolio of registered products.
Seamless transition and lifecycle management for 50+ marketed products
A client’s portfolio of 50+ marketed products required immediate and ongoing support to ensure business continuity on a global basis.