Introduction

This Fortune 100 client has two biologics that are intended to help with blood clotting post surgery. Their products were authorized by the European Medicines Agency (EMA) via the centralized procedure. The client wanted to perform a gap analysis internally to identify any unaccounted regulatory requirements in 18 different EU and non EU countries.

Business Challenge

Even after products are authorized by the EMA, there are still country-specific requirements that need to be complied with prior to marketing products in respective domestic markets. In previous such cases, the client hired a single US-based consulting company to oversee 18 different European markets. Relying on a single data point can significantly increase the chances of making a wrong decision. In this case, the client was misguided. They lacked particular requirements from various markets.

Solution

RegDesk’s unique expert-sourced regulatory intelligence product helped the client obtain reliable knowledge of national regulations from 54 local experts. Our insistence on using multiple local experts ensured that we presented the most relevant information while highlighting consensus and dissent among experts. The client not only gained knowledge and insights of each market but was also relieved by the validity of the information received since it was verified by multiple experts.

Results

Engaging 54 experts across 18 countries for a period of 6 weeks to source, collate and present the information decreased the time our client would need for a similar exercise by 88% while cutting the risk by 75%.

Why RegDesk

RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at desk@regdesk.co or visit www.regdesk.co