Post-approval lifecycle management extends well beyond marketing authorization, requiring careful handling of renewals, CMC variations, labeling updates, and regulatory information management. Challenges include inconsistent timelines, divergent authority decisions, and local requirements, making harmonization difficult. A resilient regulatory strategy demands planning, cross-team collaboration, transparent communication, and stakeholder alignment. Partnering with experienced providers offers end-to-end support, flexible technology models, and access to Local Qualified Persons for Pharmacovigilance (LQPPVs), now required in 40+ countries. These experts enhance compliance, streamline processes, and enable proactive risk management.

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