Regulatory consulting case studies
Explore our expertise and success stories.
Explore our list of consulting case studies, from asset development to regulatory affairs.
ICON has over three decades of experience in advising clients, from molecule to medicine.
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Investigational New Drug (IND) Application
A small company, with limited internal resources, was planning to submit two new INDs and reached out to ICON to help manage the IND filings.
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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.