Insights That Move You Forward

Helping you make smarter decisions, avoid costly missteps, & bring safe, effective products to market with confidence

Crystal Norwood 11/15/25 Crystal Norwood 11/15/25

The Growing Role of Real-World Evidence in Regulatory Decisions

Real-world evidence (RWE) is reshaping regulatory decisions, supplementing clinical trial data with insights from EHRs, registries, and digital tools. Regulators now rely on RWE to strengthen approvals and post-market surveillance. See how NMCG helps sponsors design data strategies that anticipate this evolving landscape.

Crystal Norwood 9/1/25 Crystal Norwood 9/1/25

Global Market Prep: EU Documentation Basics

Breaking into the EU market requires more than CE marking—it demands MDR-compliant documentation that withstands Notified Body scrutiny. From CERs to PMS plans, weak files cause costly delays. Discover the essentials and how NMCG helps sponsors prepare submissions that accelerate EU market access.