Indegene accelerated Hazard Evaluation and Risk Analysis for over 50 devices at a multinational pharmaceutical company developing innovative drugs and vaccines, achieving 100% timeline adherence and full ISO compliance. Following a major medical device acquisition, challenges included remediating a massive risk file repository and addressing audit-driven improvement initiatives for safety, efficacy, and regulations. Indegene's specialized software automated risk assessments, standardized evaluations, and streamlined remediation workflows across the portfolio. This ensured rapid, compliant processing, mitigated audit risks, and upheld product safety standards efficiently.

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