Regulatory consulting case studies
Delivering strategic regulatory consulting across the product life cycle
Encompassing over 1,000 experts across more than 100 locations we deliver customised, end-to-end regulatory solutions tailored to your needs.
Combined study with in vitro device investigating an oncology treatment
A study sponsor was investigating a biological treatment for oncology patients in addition to the standard of care chemotherapy. They sought regulatory support from ICON due to the study’s complexity, the geographic span and because the IVD was used out of its intended purpose.
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Regulatory Strategy in Clinical Development (EU)
"A large pharma customer sought expert regulatory support from ICON for a paediatric rare disease development
program."
program."
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.