FDA
Reviewer
Expert-level review of submission materials that gets you FDA-ready.
FDA Reviewer uses agentic, multi-step reasoning to evaluate submissions and internal documents against relevant regulations and guidelines. It identifies gaps, inconsistencies and missing evidence, and suggests concrete actions before anything is sent to authorities or partners.
You provide draft submission materials. FDA Reviewer evaluates them against applicable regulatory requirements to get you FDA-ready.
Key Features
Submission reviewer agent
Dedicated reviewer agent for in-depth evaluations covering all sections of FDA submission (eSTAR).
Requirement-based evaluation
Requirement based evaluation using comprehensive regulatory knowledge base.
Content gap identification
Gap identification for missing, incomplete, or inconsistent content across documents.
Evidence-backed structured outputs
Structured outputs backed by regulatory evidence for internal review and audit.
Get a structured list of issues to address rather than staying with a vague sense that something is missing.
Who can benefit from Guideways.ai?
Startups & Scaleups
Designed to give you an expert-level review before you submit, without relying solely on external consultants.
- Less back and forth
- FDA and eSTAR aligned review
- Clear, prioritized fixes
MedTech Companies
Adds scalable review capacity when teams are overloaded or submissions spike, with consistent review logic across products and reviewers.
- Scalable capacity on demand
- Consistent gap and severity view
- Faster internal alignment
Regulatory Consultants
Reduces manual document-heavy work while keeping expert-level quality.
- Less manual document work
- Higher throughput per team
- Faster cross-document review
Each group follows a different path but faces the same bottlenecks. Guideways helps them all move forward.