Our Experience
With a proven 95%+ success rate across engagements, Broom Street Associates brings deep expertise and an impressive track record.
We have prepared:
- 50+ Pre-IND packages
- 50+ INDs for first-in-human studies
- Numerous IDEs and combination product submissions
Our team has successfully resolved long-standing FDA clinical holds, including programs in atrial fibrillation (11 years), glioblastoma, pancreatic cancer (8+ years), and allergic rhinitis.
We provide comprehensive support in manufacturing, toxicology, clinical development, and global regulatory strategy (US, EU, China, and beyond).
Clients benefit from flexible monthly retainers, unlimited access to our experienced team, and direct leadership in regulatory meetings — all designed to help you reach your milestones efficiently.
We have provided rapid, comprehensive due diligence to private equity firms, venture capitalists, and family offices considering life sciences investments.
Our Story
Broom Street Associates was founded in 1999 by Anne E. Glass, RN, CCRN, CEO with a vision to provide high-quality regulatory writing services for pharmaceutical companies.
Over the past 27 years, we have grown from a specialized regulatory support firm into a trusted partner for early-stage drug, device, diagnostic, and combination product development.
Based in the Philadelphia-Wilmington area, we have expanded our reach globally while maintaining strong roots in supporting academic centers, startups, entrepreneurs, and both private and public companies.
Today, we continue to operate with the same hands-on, collaborative spirit that has defined us since the beginning.
Our mission: We are dedicated to advancing biomedical innovation by removing regulatory and development barriers that slow progress.
Our Growth Timeline
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