A connected Quality and Regulatory Affairs (QARA) ecosystem helps close gaps between FDA approval and commercial success by integrating QA and RA early in development. Delays in approvals can render products obsolete, while siloed teams slow innovation. Embedding QARA as a market access function reduces duplication, accelerates launches, and ensures compliance across global markets. AI enhances QARA by spotting safety trends, modeling manufacturing changes, and automating routine tasks, though human oversight remains critical. As AI adoption grows, QARA roles will evolve toward strategic decision-making, risk mitigation, and regulatory collaboration to deliver safe, effective therapies worldwide.

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