Case Study

Indegene Fast Tracks Canadian Annual Summary Reports (ASRs) Submission for Class IV Medical Devices

Indegene Fast Tracks Canadian Annual Summary Reports (ASRs) Submission for Class IV Medical Devices

Pages 2 Pages

Indegene fast-tracked Canadian Annual Summary Reports (ASRs) submission for Class IV medical devices at a multinational healthcare company specializing in medical, surgical, laboratory products, pharmaceuticals, and clinical offerings, achieving 25-30% productivity gains, 100% first-time-right draft acceptance, and full CMDR (SOR-98-282) compliance. The company collaborated with Indegene to develop new ASRs for two key products. Indegene's efficient software automated data aggregation, standardized reporting templates, and streamlined review workflows per Health Canada guidelines, ensuring timely, accurate submissions and enhanced regulatory processes.

Join for free to read