Insights That Move You Forward

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

Crystal Norwood 8/15/25 Crystal Norwood 8/15/25

Real-World Impact: Poor Data Integrity Examples from Recent Rejections

Regulatory rejections often stem from preventable data integrity failures—like falsified lab results, poor traceability, or incomplete safety documentation. These errors delay patient access and damage credibility. Learn from real-world examples and see how NMCG helps sponsors safeguard submissions from costly pitfalls.

Crystal Norwood 6/15/25 Crystal Norwood 6/15/25

What to Expect from an FDA Pre-Submission Meeting

FDA Pre-Submission meetings offer critical insight into regulatory expectations before you invest time and budget. From strategy planning to meeting facilitation, NMCG helps sponsors maximize feedback, reduce delays, and approach FDA reviewers with confidence and clarity.