Regulatory consulting case studies

ICON’s Regulatory Project Managers (RPMs) were approached by a client to deliver, in parallel, an initial US Biologics License Application (BLA) and an EU Marketing Authorisation Application (MAA) Major Amendment for a new formulation within an existing program.

ICON’s Regulatory Project Management (RPM) team was approached by a client to help establish a global footprint and reduce the approval timelines for the first wave of targeted countries located in the US, Europe, and Asia Pacific.

ICON was asked to support a client with migrating data from an existing Regulatory Information Management (RIM) system into a new system. During migration, the ICON team needed to ensure the safety reporting requirements were correctly described in the new system as current data were incorrect and/or incomplete.

ICON was asked to provide scenario planning related to accelerating the marketing authorisation application (MAA) approval through various clock-stop scenarios.

Following a corporate acquisition, the ICON Regulatory Technology & Information Management (RTIM) team was engaged by a mid-sized life sciences company to re-design, configure, and deploy the existing EDMS to a new business unit.

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.