Accelerate submissions without compromising quality.
You know what the FDA expects. The bottleneck isn't judgment, it's the weeks spent manually extracting evidence from hundreds of Module 2.5 documents.
The competitive reality: Top-quartile regulatory functions deliver submission-ready packages in 56-84 days from database lock.
The arithmetic is unforgiving:
Every day of delay = $500K in unrealized revenue ($1.4M/day for cardiovascular assets)
Every month of timeline compression = ~$60M in NPV for a $1B asset
Average development timeline: 10.5 years, consuming half your patent term
Each week saved isn't just revenue—it's patent life you'll never get back
Start with your next major submission
Work with us in parallel to your standard process to prove the timeline compression on one NDA or BLA submission.
Measure the days saved, the error reduction, the hours of regulatory science freed from document assembly.
Scale across your portfolio.
The math: If you accelerate 4 major submissions by 13 weeks each, that's 1 year of patent life preserved, potentially worth billions in captured revenue.