Audubon’s delivery of multiple high-quality accelerated regulatory filings has set new industry benchmarks for excellence. We consistently deliver filings 6 to 8 weeks after database lock, exceeding our clients’ targets and achieving best-in-class timelines1. Effective planning, communication strategy, lean processes, and teamwork are essential for success.
 

Database Lock

Submission to Regulatory Agencies

9–10 WEEK TARGETS

Timelines Achieved

8 WEEKS
7 WEEKS 2 DAYS
6 WEEKS 4 DAYS
6 WEEKS 3 DAYS
6 WEEKS
 

¹ McKinsey & Company’s benchmarking data of 62 pharma companies.Mihic A, Raschke R, Agrawal G, Berghauser Pont L, Poetes R, and Ferretti G. Rewiring pharma’s regulatory submissions with AI and zero-based design. August 1, 2025 (cited November 2025). Available from: https://www.mckinsey.com/industries/life-sciences/our-insights/rewiring-pharmas-regulatory-submissions-with-ai-and-zero-based-design.