Scale your regulatory practice without losing depth
For regulatory consultants supporting medtech and digital health teams.
As a consultant, you are expected to give fast, defensible regulatory answers but still need to spend significant time manually piecing together guidances, precedents, and rationales.
Sounds familiar?
Repeat work
Research tasks repeat across projects. Information is manually reformated across documents.
Expert time drain
Senior staff get spread across many engagements creating bottlenecks and inefficiencies
Faster timelines
Clients expect faster timelines while devices and software grow more complex.
Outdated tools hold you back
Legacy tools and generic chatbots are not tuned to deal with the complexity of regulatory questions.
Slow consultant onboarding
Training new consultants to your standard is slow and hands-on.
Increasing complexity
Challenge maintaining the bar for quality while demand and complexity rise.
Guideways automates deep regulatory analysis and first-pass review so you can keep your focus on strategy and client advice. Classification options, pathways, mapped requirements, and compliance checks are handled in the background and returned as evidence-backed outputs.
Expert-level regulatory intelligence that fits your workflow
Guideways supports the scoping, analysis, and review you already do. It reduces manual effort, freeing up senior staff time for interpretation, judgement, and client discussions.
FDA Sherpa
Frame the path from the first call
From a client’s device description, FDA Sherpa identifies classification candidates and likely pathways, then provides a high-level map of relevant regulations, guidances, and standards. This supports faster qualification of new projects and clearer expectations on scope and risk.
FDA Reviewer
Standardize pre-submission checks
Structured checks against identified requirements across clients highlight missing content, inconsistencies, and weak support early in the review process. The result is concrete, prioritized action lists.
FDA Researcher
Deepen positions without extending timelines
Research across regulations, guidances, standards, and approvals delivers evidence-backed answers with linked references you can cite and challenge. This creates a reusable evidence base for similar devices and indications.
Guideways accelerates your workflow, helping you to scale your business
Early scoping and proposal preparation
Pre-submission reviews and internal quality checks
Detailed device or portfolio analysis
Ongoing advisory work and follow-up questions from clients
Outputs can be exported and integrated into your reports. You decide how findings are interpreted and presented. Guideways makes the underlying analysis more efficient, consistent, and traceable.
“Guideways can automate these tasks, saving valuable time and resources to focus on activities that require our specialized expertise.”
What you gain as a consultant?
Guideways helps you handle more projects per consultant without lowering your standard, shortening research cycles for complex regulatory questions and ensuring more consistent analysis across clients, devices, and consultants.
We can show you the full workflow on one of your devices in a live demo.
