We are thrilled to announce that our medical devices team collected the Support award at TOPRA’s 10th Awards for Regulatory Excellence.
The Awards celebrate the achievement of individuals, teams and organisations in the wider healthcare regulatory affairs community.
The Support Award was in recognition of the critical role Regulis played in the development and registration process of a medical device for a client.
TOPRA summarised the achievement as follows:
“It has been a turbulent time for the medical device industry over the past few years. Like many device manufacturers, Prevacept Infection Control has experienced challenges navigating the changing European regulatory environment and withdrawal of many notified bodies. Prevacept is a small US company with a single product – a lock solution to maintain catheter patency in haemodialysis. For the past 4 years the company has worked closely with Regulis, which has consistently offered exemplary regulatory strategic, commercial and operational support. Regulis has demonstrated outstanding medical device and medicinal product regulatory affairs expertise, an ability to understand complex scientific data and the skills to effectively engage with regulators. While Prevacept is still awaiting formal CE marking of its innovative medical device with ancillary product, Regulis has been instrumental in ensuring that EU approval will be secured. The Regulis Team worked with passion and commitment to drive projects to a successful conclusion.”
The winners of the 2019 Awards were announced on 21st November at a sparkling ceremony in London, UK. The Awards were judged by a panel of respected figures in the regulatory field.
Commenting on the Award, Managing Director Kim Wharton said “Winning the TOPRA Support Award is recognition of the expertise, hard work and dedication of our regulatory devices team and we are very proud to be the first company to win this Award twice”.
As ever, we will strive to continually improve our services, and we hope to be shortlisted at next year’s Awards too!