Regulatory operations are evolving as biopharma faces stricter timelines, global complexity, and rising data demands. Proactive strategies now span manufacturing, labeling, supply chain, and pharmacovigilance to avoid delays and ensure compliance. Smaller firms often outsource, while larger ones use hybrid models to balance resources. Key trends include UK’s recognition scheme, EU-FDA collaborations, and CTR transitions. Automation in publishing and labeling, AI-driven analytics, and flexible service models enhance efficiency and accuracy. Strong governance and partnerships enable continuous improvement, while AI/ML tools support compliance monitoring, real-time intelligence, and long-term lifecycle optimization.

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