01
Structure the strategy
Connect the intended claim to the supporting studies, endpoints, evidence thresholds, assumptions, risks, and alternative paths.
Regulatory Designer
Build a traceable regulatory development plan for every FDA decision.
Connect the intended claim, evidence strategy, studies, evidence gaps, FDA questions, agency feedback, decisions, risks, commitments, and development timeline in one controlled planning workspace.
Interactive example development program · No account required.
Example development program
See Regulatory Designer applied to a complete regulatory development plan.
Explore an example JAK1 development strategy for moderately to severely active ulcerative colitis. Follow the intended claims, clinical studies, FDA meetings, risks, decision points, dependencies, and development timeline in one connected program.
JAK1 Ulcerative Colitis Development Strategy
4Claims
3Studies
3FDA meetings
4Risks
58Connections
Controlled development workflow
From regulatory strategy to controlled execution.
Regulatory Designer preserves the reasoning behind the development program before, during, and after an FDA interaction.
02
Prepare the FDA decision
Build focused questions around the uncertainties that will materially change the development program.
03
Capture agency feedback
Record the response, disposition, source, sponsor interpretation, and affected elements of the program.
04
Govern the decision
Preserve what was decided, why it was chosen, which alternatives were considered, and what would trigger reconsideration.
05
Control execution
Assign commitments, review a frozen candidate, approve the program version, and generate the regulatory record.
Connected regulatory intelligence
Research the evidence without leaving the regulatory workflow.
Use connected regulatory intelligence to investigate precedent, understand the approved landscape, and retain the context that informs development choices.
Product Explorer
Search approved products, indications, targets, companies, and regulatory timelines.
Explore productsNetwork Graph
See connected product, disease, target, and company relationships in context.
Open the graphCompare & Portfolios
Compare selected assets and retain focused landscapes for continued review.
View portfoliosPlans
Explore evidence. Build strategy. Collaborate.
Start with connected regulatory intelligence for free. Use Pro to build and retain strategies yourself, or choose Teams to work in a shared workspace.
Free
Explore evidence and qualify programs before committing to a workspace.
- Product Explorer and Network Graph
- 5 Explorer searches and 5 Network Graph queries per month
- Read-only qualification workflow
Pro
For individual users building and retaining personal regulatory strategies.
- Personal regulatory development workspace
- Regulatory Designer for claims, studies, evidence, and FDA questions
- Evidence research, landscape reports, and data exports
- Personal versions for recurring program review
Teams
For companies coordinating shared programs across regulatory and development functions.
- Everything in Pro: evidence research, reports, exports, and Regulatory Designer
- Shared company program workspace
- Roles, admin-managed access, and shared workflows
- Version history, branching, and publication controls
- Shared regulatory programs with role-based access and governed publishing
Designed for scrutiny
Expose assumptions, gaps, dependencies, and alternatives instead of hiding them in a static slide.
Careful by design
Structure public regulatory and scientific information without presenting it as medical advice or a guaranteed outcome.
Build the reasoning, not just the artifact
Give your next regulatory decision a visible structure.
Explore a complete example program, then use Regulatory Designer to build and govern your own strategy.