Regulatory Guidance for Established Products
Case study
Strategic regulatory services
Challenge
A top-10, multinational pharmaceutical company needed to enhance product support and improve its in-house development.
The company sought to improve in-house focus on the development pipeline and looked to ICON in outsourcing US regulatory support for 27 mature products.
Solution
ICON answered this challenge by matching the company with our specialists to act as US project managers and direct contacts with FDA. We established a flexible project model employing regulatory experts with a broad range of therapeutic area expertise and decades of industry experience. Based on experience, ICON offered a realistic plan to approach the necessary regulatory transition and training.
ICON’s value add
Our dedicated strategic regulatory experts serve clients around the globe to help navigate complex global requirements and address trends and emerging issues over the entire product lifecycle.
- 30+ years of experience
- Experience with regulatory agencies in over 60 countries
Outcome
ICON regulatory experts oversaw the seamless integration with systems developed by internal teams and provided project teams with both US and global perspectives. This resulted in a focused and unbiased approach to meeting client needs and a dedicated point of contact with the FDA acting as US Project Managers.