Regulatory consulting case studies

A top-10, multinational pharmaceutical company needed to enhance product support and improve its in-house development.

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.

ICON provided regulatory support for a study to develop a novel treatment for patients using an implantable combination product and three separate medical devices.

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.

"A large pharma customer sought expert regulatory support from ICON for a paediatric rare disease development
program."

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.

A client’s portfolio of 50+ marketed products required immediate and ongoing support to ensure business continuity on a global basis.