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Case Study

Life Science and Regulatory Platform

Business Challenge

The client is a leading regulatory consulting firm, specializing in global medical device and IVD compliance. They not only help organizations in transitioning to new regulatory schemes but also work towards reducing process time. They ensure quality that meets global regulatory standards to obtain quick approvals.

Solution Delivered

Fission Labs developed a Regulatory Affairs Management Suite (RAMS), specially designed to cater to the customers in the core Regulatory Affairs Management System. We developed compliance-focused regulatory results to serve their wide customer base. RAMS 2.0 helps the organization achieve greater efficiency and speed up the Medical Device FDA approval process with its advanced report generation techniques.

The Business Benefits Rendered

Over 12000 Device Companies are active on RAMS.
Efficiently tracked 8000+ Regulatory Certificates.
100k+ devices placed in the market by the client company.

Salient Features of the Platform

Streamlined Medical Device Regulatory Processes
Hassle-free certification expiry management and monitoring
Simplified digital interface
Smooth and accelerated FDA approval process
Innovative report generation techniques
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