Our team is deeply experienced in FDA Regulatory Submissions (510Ks, PMAs, INDs, NDAs, De Novo, etc.), Global Product Registrations, CMC, QMS Implementation & Compliance, Medical Safety, Post-Marketing Surveillance, EU MDR and EU IVDR, Clinical Evaluation Reports, ISO 13485:2016, MDSAP and many other quality and regulatory challenges faced by our industry.
Have you paid hundreds of dollars per hour for advice without results? Do you prefer someone to take work off your plate and get things done? Have your budgets for outside help been cut? Our team is deeply experienced and handles projects from start to finish. Your budget dollars stretch much further as our consultants quickly blend with your team and deliver results.
Have you tried filling your resource gaps through your general staffing vendor and/or vendor management system only to find many unspecialized, unqualified candidates? You are not alone! Many of our clients come to us for our specialized expertise in Quality & Regulatory Compliance. We most likely have a consultant on our team with the specific expertise you need.
After 12 years in the industry, we have built a team of trusted consultants that consistently receive exceptional feedback from our clients. Our consultants are our W-2 employees and work with us for many years on multiple projects. You get the benefit of tested expertise exactly when you need it. Contact us today so we can understand your specific need and bring the right consultant from our team to help you!
“First and foremost, PRP is Customer-Focused! They truly want you to succeed and work toward that goal in mind. PRP partnered with us and provided exceptional consulting. When I am speaking with PRP, I feel as though I am their most important client! Thank you, PRP.”
“We are so happy to be working with you and your PRP experts. It truly has put my mind at ease knowing that we now have the support we need to help deal with the EU MDR initiative head-on.”
Since 2012, Professional Resource Partners (PRP) has been honored to serve as a trusted source of quality and regulatory compliance consultants to the medical device and diagnostics industries. In 2017, we launched PRP Quality which specializes in Automotive Quality inspection, sorting, and containment. As an ISO:9001 Certified Business and a WBENC Certified Woman-Owned Business, our company is proud to deliver exceptional professional integrity and service to the many clients we support with our customized approach. It’s also the reason why, when PRP is involved, client expectations are not simply met, but they are consistently surpassed.