How RegAccel Works

RegAccel begins with a guided conversation that collects information about your product, studies, and regulatory strategy. Instead of navigating complex software menus, you simply answer questions in plain language.

What makes this different: The wizard understands regulatory context. It asks follow-up questions, explains FDA requirements in plain language, and helps you identify which documents you'll need.

You upload source documents (study reports, protocols, SOPs, analytical methods) and the system automatically categorizes them based on your answers.

RegAccel automatically organizes your uploaded documents into a structured knowledge base, understanding how your product, studies, and manufacturing processes connect to regulatory requirements.

The result: When you need to reference a stability study in multiple sections, the system knows exactly where that data lives and how to cite it properly.

Every claim is automatically traced back to source documents, which is essential for FDA inspections.

RegAccel uses regulatory templates developed over 13 years of FDA consulting work. These aren't generic document templates, instead they're intelligent workflows that know how to structure IND submissions, BLA modules, and 510(k) applications according to FDA guidance.

Built for non-experts: The system explains regulatory requirements in plain language, provides examples of what FDA expects, and guides you through complex concepts like CMC documentation without assuming prior regulatory knowledge.

Using your organized knowledge base and expert templates, RegAccel generates compliant draft content for each section of your FDA submission.

Built-in accuracy: Unlike generic AI writing tools, RegAccel only generates content that can be traced back to your source documents. Every claim includes automatic citations.

This is not "AI writes your submission." This is AI-assisted drafting with expert regulatory templates that you review and approve.

A regulatory expert reviews the generated content for accuracy, compliance, and completeness. You review and approve the final submission before filing with FDA.

Complete audit trail: Every version, every change, every decision is tracked. When FDA asks "where did this data come from?", you have instant answers with exact source citations.