thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

North America IVD

August 16, 2022

Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices

GUIDANCE DOCUMENT - Guidance for Industry and FDA Staff AUGUST 2022 In 2003, FDA issued an updated guidance on the "Replacement Reagent and Instrument Family Policy" for in vitro diagnostic (IVD)...

IVD IVDR

February 2, 2022

Roadmap for Successful IVDR Transition

Roadmap for Successful IVDR Transition: The compliance dates for the In Vitro Diagnostics Regulation (IVDR) will become effective on May 26, 2022. To help you with the IVDD to IVDR transition, we've...

Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.