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MarketReady AI / commercial plans

Pricing & Plans

From your first submission to a global device portfolio. Align your evidence, regulatory investment and next market.

US · Canada · EUMDSAP-aligned evidence reuseHuman-reviewed readiness

Prices in USD · Taxes calculated at checkout. Annual plans renew yearly; Submission Pass is a one-time purchase.

Project-based

Submission Pass

One device. One target market.

$3,500 USD

one-time · 12-month access

  • 1 submission workspace / jurisdiction
  • Up to 5 team members
  • Document reconciliation & evidence review
  • Gap assessment & readiness reports
  • FDA predicate search for US submissions

International growth

Multi-Market Pro

A portfolio with international ambitions.

$15,000 USD

per year · billed annually

Equivalent to $1,250/month · charged annually

  • Unlimited active submissions · US, Canada & EU
  • Up to 15 team members
  • Parallel EU dossier & evidence crosswalk
  • MDSAP audit tracker & market coverage
  • Manual regulatory updates & cited Ask Guidance
  • ROI & capital planning modeler

Custom engagement

Enterprise / Firm

Manufacturers and regulatory consulting teams.

$35,000 USD

per year · custom scope agreed separately

  • Portfolio-wide planning & evidence workflows
  • Unlimited seats & submissions in proposed scope
  • Tailored onboarding and implementation
  • Multi-client and branding needs scoped together
  • SSO & custom requirements subject to agreement

Expertise alongside your evidence

Discuss an optional human regulatory review with LoweRiskQA Consulting Inc. Scope and fees are quoted separately.

Plan your market sequence

Compare MDSAP-aligned preparation and parallel filings with a sequential strategy. Regulatory filing fees, auditor costs and professional services are separate from software pricing.

Find the right fit for your next market.

Talk through your portfolio and priorities.