Regulatory ImpactRegulatory Impact
Regulatory Designer Strategy workspace for drug development

Build the regulatory development plan before the next FDA decision.

Connect the intended claim, studies, evidence gaps, FDA questions, risks, and fallback paths in one reviewable program. Prepare for a pre-IND or end-of-Phase 2 meeting, resolve pivotal evidence strategy, align teams before protocol finalization, or present the plan to leadership and investors.

Start free, then build Explore the evidence first

Free access includes Product Explorer and a read-only qualification workflow. Regulatory Designer is available with Pro and Teams.

Regulatory Designer canvas showing a connected regulatory strategy workflow
Regulatory DesignerMap decisions, studies, submissions, and FDA interactions
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From landscape to execution

A regulatory strategy is more than a timeline.

Regulatory Designer keeps the reasoning behind a program visible. Teams can see what supports a claim, what remains uncertain, what to ask FDA, and where a fallback becomes necessary.

01

Frame the decision

Connect the intended claim to assumptions, evidence gaps, risks, and fallback positions.

02

Design the evidence path

Lay out study architecture, endpoints, evidence thresholds, and decision points.

03

Plan FDA interactions

Sequence meeting questions, submissions, review periods, and anticipated FDA actions.

See Regulatory Designer
The evidence layer

Research the landscape without leaving the workflow.

Use the broader workspace to investigate the approved market, examine relationships, and retain the context that informs your regulatory choices.

Product Explorer

Search approved products, indications, targets, companies, and regulatory timelines.

Explore products

Network Graph

See connected product, disease, target, and company relationships in context.

Open the graph

Compare & Portfolios

Compare selected assets and retain focused landscapes for continued review.

View portfolios
Plans

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.

$0
  • Product Explorer and Network Graph
  • 5 Explorer searches and 5 Network Graph queries per month
  • Read-only qualification workflow
Start Free
Best for individual strategy work

Pro

For individual users building and retaining personal regulatory strategies.

$149/month
  • 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
Start Pro Workspace

Teams

For companies coordinating shared programs across regulatory and development functions.

$399/month
  • 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
4 named seats included; 200 saved designs across the workspace.Start Teams
Local Regulatory Designer downloads are unlimited. Workspace limits apply only to designs stored in Regulatory Impact.

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.

Begin with the free evidence workspace, then move into Regulatory Designer when you are ready to build.

Start free, then build No credit card required to create a free account.