920 Aspen Court, Boston
9:00am – 5:00pm (Mon-Fri)
Requalite offers a customed and flexible menu of solutions for its clients need in compliance process. We administer amendable solutions for your requirements, whether you are in search of one-time individual project, or looking for a long-term support. We modify our solutions as per the clients capacity and resources to address regulatory and clinical services.
Requalite provides customized Regulatory and Clinical Services as per the clients requirements. Whether you need support for one single device or several products, whether you are a start-up or an established enterprise, whether you require a single element of regulation or you need entire Regulatory support, Requalite has bespoke formula to guide you through your compliance journey!
Requalite guides you through your compliance processes based on specific project needs. We identify the components and the boundary of your requirement in a single project with defined deliverables and timeline. From Kick-off to Close-out Requalite is always with you to successfully complete your regulatory project.
Requalite also provides services for your stand-alone needs within the predefined hourly timelines. In this approach, each deliverables is assigned to a specific hour to be completed for individual regulatory documents and services.
Requalite helps you navigate your regulatory strategy for your products in EU compliance. We support you to develop best solutions within the most attainable timeline to obtain your certification. In the whole regulatory approach, we provide all the elements of the relevant regulations including technical file preparation, quality management, risk management, performance/clinical evaluation, clinical study, post-market surveillance and vigilance.