Case Study: a Fortune 100 company accelerates EU product launches with RegDesk

Regulatory Gap Analysis of Centrally Authorized Biologics in the European Union

The Fortune 100 company's subsidiary needed to introduce two new pharmaceutical products across 18 EU and non-EU countries but was challenged by the complexity of identifying all country-specific regulatory requirements. To avoid the risk of inaccurate information from their previous consulting agency, the company engaged RegDesk and its regulatory intelligence product for a solution.

RegDesk implemented a solution by crowdsourcing expertise from 54 vetted consultants across the target countries to provide a peer-reviewed gap analysis. This approach gave the company a clear and reliable picture of all regulatory requirements. The results were significant, as RegDesk helped the company cut its regulatory strategy timeline by 88%, reduce regulatory risk by 75%, and save 11 months in the product launch process.