A mid-sized UK based pharmaceutical company held a mature hospital-use IV product that was authorised in over 20 countries, including the EU, US, Japan, and various Rest of World (RoW) markets.  The product, though not a primary focus for the company, continued to generate significant revenue. Clinigen provided strategic regulatory support and efficient management, ensuring sustained product compliance across diverse international markets. Their comprehensive approach included maintaining marketing authorisations, supporting unlicensed supply routes, and obtaining new licences in Rest of World markets. This enabled the client to focus on core business activities while protecting revenue and expanding market reach.

Read the case study to learn how Clinigen’s expertise and proactive strategies played a major role in navigating complex regulatory landscapes, and achieving the client’s commercial objectives.