Vendor Sheet
IQVIA RSS Services: Your Regulatory Partner When You Need It Most
IQVIA’s Regulatory Science and Strategy (RSS) team helps sponsors navigate FDA and global regulatory engagements with a 100% success rate in securing formal meetings. Staffed largely by former FDA experts, RSS supports drugs, biologics, and devices across 35+ indications, offering strategy development, meeting requests, briefing docs, regulator query prep, and post-meeting follow-up. Expertise spans oncology, psychiatry, and rare diseases, with deep knowledge of CBER, CDER, CDRH, EMA, MHRA, PMDA, and Health Canada. Customized strategies, specialist networks, and real-world evidence strengthen regulatory positioning, saving 3–4 months per interaction and reducing approval delays.