FDA Submissions at 1/5th the Cost

RegAccel helps small biotech companies create compliant regulatory submissions in weeks, not months, without $200K consultant fees.

The Regulatory Bottleneck

Small biotech companies face an impossible choice when preparing FDA submissions.

Traditional regulatory consultants charge $150K-$500K per submission. For pre-revenue companies, that's often 20-40% of available runway.

Hiring in-house regulatory talent requires 6-12 months minimum. Most small biotechs can't afford the time or $150K+ salaries.

Every month of regulatory delay means competitors move ahead, partnerships fall through, and promising therapies sit on the shelf.

Result: Innovative therapies never reach patients because the regulatory process is too expensive and time-consuming for small companies.

RegAccel combines expert regulatory knowledge with AI automation to deliver enterprise capabilities at startup pricing.

70%

$15K-$50K per submission vs. $150K-$500K traditional consultant fees

Save $400K-$2M annually on regulatory work

75%

4-8 weeks vs. 6-12 months traditional timeline

Get to market faster, preserve runway, beat competitors

100%

Full traceability with automatic source citations for every claim

Built by 15-year FDA regulatory consultant

Enterprise regulatory capabilities. Startup pricing. Expert compliance.

Upload your study data and regulatory documents through our guided conversational workflow. Like training your AI Director of Regulatory Affairs.

AI creates compliant FDA documents using expert templates. Every sentence includes automatic source citations for FDA inspection.

Regulatory expert validates output, you approve final submission, file directly with publisher. Complete audit trail included.

Built-in compliance from day one. Every generated claim is automatically traced back to your source documents.

RegAccel was founded by regulatory and AI experts who saw promising innovations delayed because regulatory submissions were too expensive.

COO & Co-Founder

15+ years FDA regulatory consulting. Expert in IND/BLA submissions and CMC documentation.

CEO & Co-Founder

AI/ML founder building production systems for regulated industries. Technical architect for RegAccel.

Join our pilot program and be among the first biotech companies to experience affordable, AI-powered FDA submissions.