IQVIA’s Global Regulatory Affairs services help life sciences organizations manage rising regulatory complexity, with over 2,000 new regulations, 300% growth in mandates, and significant pricing pressures. Combining expert resources, AI/ML-driven workflows, and global coverage, IQVIA delivers strategic advice, marketing applications, regulatory maintenance, and lifecycle support. Services include submissions for BLAs, MAAs, and biosimilars; global labeling; safety reporting; clinical and CMC regulatory guidance; and portfolio optimization. With 1,900+ professionals across 65+ markets and regional hubs worldwide, IQVIA reduces time spent on repetitive tasks, lowers maintenance costs, scales flexibly, and ensures compliance with evolving global requirements.

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