Our Team

Marshall brings over 15 years of regulatory affairs consulting experience to RegAccel. He has supported FDA-regulated companies across pharmaceuticals and medical devices, with deep expertise in IND/BLA submissions and CMC documentation.

As an independent regulatory consultant, Marshall has worked with biotech companies of all sizes, from pre-clinical startups to established commercial firms. He's seen firsthand how regulatory costs prevent promising therapies from reaching patients.

Expertise: IND/BLA submissions, CMC documentation, 510(k) applications, regulatory strategy, FDA correspondence

Education: M.S. Regulatory Affairs

Every template, workflow, and compliance check in RegAccel is informed by Marshall's real-world FDA submission experience. He ensures that RegAccel delivers the same quality as traditional consultants, just faster and more affordable.

Peter is an AI/ML founder with extensive experience building production systems for regulated industries. He leads product development and technical architecture for RegAccel.

As a former enterprise AI consultant, Peter specialized in deploying machine learning systems that operate under strict regulatory and compliance constraints. He understands that in regulated industries, accuracy and traceability aren't optional features—they're fundamental requirements.

Expertise: AI/ML platform development, regulated industry technology, system architecture, enterprise software

Peter's philosophy: AI should augment human expertise, not replace it. RegAccel's architecture reflects this, as the AI handles tedious organizational work and draft generation, while regulatory experts ensure compliance and quality.

Naresh is a veteran technology leader who architects 0-to-1 solutions across mobile, web, and fintech platforms. At RegAccel, he spearheaded the architecture of the Regulatory Accelerator for Pharma, a platform that saves hundreds of man-hours per FDA submission. He specializes in slashing engineering costs for startups by delivering 5-8x output through AI-augmented DevSecOps, AI-assisted SDLC, and full-stack mastery.

With a track record of delivering $20M+ in measurable business impact, Naresh scales technology from startup to enterprise levels while ensuring 99.99% uptime and SOC2 compliance. He is an expert in building, managing, and scaling high-performing engineering teams, having previously served as Head of Engineering at Floify and in senior leadership roles at IntentHQ and Intel.

Expertise: Multiple modern full stack programming languages; multi-cloud infrastructure and Infrastructure as Code; relational and graph databases; and engineering for rigorous compliance standards including HIPAA, SOX, and SOC2.

Education: Masters in Computer Science

Naresh's work ensures that RegAccel's platform can scale from pilot customers to hundreds of simultaneous submissions while maintaining the traceability that makes the system FDA inspection-ready. He ensures that RegAccel maintains enterprise-grade reliability and security from Day 1.