Indegene established a scalable material review function for a specialty biotech company with multiple late-stage injectable products and no prior commercialization experience, anticipating 4X asset growth while ensuring US/EU regulatory compliance. Challenges included internal audit-identified compliance lapses, missing audit trails, and cumbersome email/shared drive workflows lacking standard procedures. Indegene's software implemented a centralized review platform with automated workflows, comprehensive audit trails, and standardized SOPs, eliminating manual inefficiencies and enabling rapid scaling for compliant, high-volume operations.

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