Regulatory consulting case studies

The European Medicines Agency (EMA) is in the process of implementing IDMP standards that specify standardized definitions to identify and describe medicinal products for human use only.

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 large scale regulatory resourcing solution was put in place for our client, including the transition of over 275 staff.

A biopharma partner required support with an FSP model across multiple service areas, seamlessly integrated with an existing FSO partnership.

A 10-year existing FSO partnership was expanded to incorporate a blended model to aid sourcing niche roles across multiple geographies whilst the sponsor maintained greater control of key areas.

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

A Chinese sponsor adopts a blended delivery model to realise cost savings and assume greater autonomy.