Regulatory consulting case studies
Delivering strategic regulatory consulting across the product life cycle
Encompassing over 1,000 experts across more than 90 locations we deliver customised, end-to-end regulatory solutions tailored to your needs.
Team delivered an initial US BLA and EU MAA Major Amendment (Gastroenterology)
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.
Global expansion and a reduction in approval timelines
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.
Regulatory project management scenario planning (Oncology)
ICON was asked to provide scenario planning related to accelerating the marketing authorisation application (MAA) approval through various clock-stop scenarios.
Regulatory Guidance for Established Products
A top-10, multinational pharmaceutical company needed to enhance product support and improve its in-house development.