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Plans & Pricing

Quality and compliance, built in from day one

One platform for quality management, regulatory readiness, and AI-powered gap analysis. Choose the plan that matches where you are today.

Foundation

For teams formalizing quality management for the first time and preparing for their first regulatory submission.

Edit Users5 included
Basic UsersUnlimited

Best suited for companies

  • Preparing for a first FDA or notified body audit and need to find documentation gaps before regulators do
  • Managing compliance to 1-3 standards with a lean team and no dedicated regulatory affairs function
  • Moving off spreadsheets and want existing documents mapped to regulatory controls from day one
Most Popular

Growth

For scaling organizations managing compliance across multiple markets, frameworks, and teams.

Edit Users10 included
Basic UsersUnlimited

Best suited for companies

  • Managing to many standards across multiple markets where manual processes have become a bottleneck
  • Assembling audit evidence by hand every time an inspection is approaching
  • Expanding into new markets and need to build or adapt compliance frameworks without external consultants

Scale

For mature quality operations with enterprise-grade complexity, multi-site requirements, and custom configuration needs.

Edit UsersCustom
Basic UsersCustom

What is included

  • Custom pricing
  • Custom implementation
  • Dedicated success and support

What is included

Quality Management
Document Control
Foundation
Growth
Training Management
Foundation
Growth
Supplier Quality Management
Foundation
Growth
Quality Events
Foundation
5 templates
Growth
Unlimited
Resource Library
Foundation
Product & Root Cause
Growth
Unlimited
Reporting and Analytics
Foundation
Growth
Regulated Product Lifecycle
Design Controls
Foundation
Growth
Product Development Tools Integration Catalog
Foundation
2 integrations
Growth
Up to 3
Compliance Frameworks & Dashboard
Compliance Frameworks Included
Foundation
3
Growth
5
Compliance Dashboard
Foundation
Growth
Team Collaboration on Audit Tasks
Foundation
Growth
Custom Framework Builder
Foundation
Growth
Additional Regulatory Frameworks
Foundation
Additional fee
Growth
Additional fee
Agentic Compliance Capabilities
Qualio Copilot
Foundation
Growth
AI-powered Gap Analysis
Foundation
Growth
Documentation Mapping to Controls
Foundation
Growth
AI Remediation Guidance
Foundation
Growth
Automated Evidence Collection
Foundation
Growth
Continuous Regulatory Monitoring
Foundation
Growth
Integrations
Core Integrations
Foundation
Growth
Integration Hub
Foundation
2 integrations
Dev catalog
Growth
3 integrations
Full catalog
Developer API
Foundation
Growth
Available Add-ons
Integration Hub
Foundation
2 integrations
Dev catalog
Growth
3 integrations
Full catalog
Content Pathways
Foundation
Additional Edit Users
Foundation
Additional fee
Growth
Additional fee
Multiple Instances
Foundation
Additional fee
Growth
Additional fee

Integrations

Connect your entire tech stack

All plans include core integrations at no additional cost. The Integration Hub add-on extends connectivity across your full tech stack. Foundation customers access the development tools catalog. Growth customers access the full catalog.

Foundation — Core & Dev Tools Catalog

Included: SSO, OneDrive, Jira. Integration Hub add-on unlocks dev tools.

SSOOneDrive / SharePointJiraGitHubAzure DevOpsIntercomTestRailZephyrScaleAsanaXrayGitLab

Growth — Full Integration Catalog

Everything in Foundation, plus the complete catalog including CRM and support tools.

SSOOneDrive / SharePointJiraSalesforceHubSpotIntercomGitHubAzure DevOpsZendeskMicrosoft DynamicsTestRailZephyrScaleAsanaXray CloudGitLabLinear

Frequently asked questions

How does pricing work?

Qualio works with life science companies of all shapes and sizes, and our pricing is built to match their specific operational needs. After an initial conversation to understand your business and requirements, we will provide a tailored quote.

Is Qualio priced as a one-off or recurring cost?

Qualio is a modern, cloud-based software provider that offers an annual recurring subscription model. Your subscription includes all platform updates, cloud storage, and support — with no hidden fees.

Can we add more users later?

Yes. Additional edit users can be added at any time. Basic users are unlimited in both plans at no additional cost.

How long does implementation take?

With the right preparation from your team, most customers are live within 30 to 60 days. Our onboarding team is made up of industry experts who guide you through every step.

Can Qualio support multiple instances?

Yes. Growth customers can add additional instances to manage multiple sites or entities, with easy navigation between them. Talk to us for details.

Is data storage included?

All cloud storage is included in your subscription. Qualio is ISO 27001 certified, so your quality data is protected to the highest standards.

Which regulatory frameworks are supported?

Qualio supports FDA, GxP, and ISO standards. Foundation includes 3 frameworks. Growth includes 5. Additional frameworks are available as an add-on.

What does customer support look like?

Our global support team provides weekday chat and email support. 86% of customers self-serve through our Knowledge Base, but we are always available when you need us.

Ready to see Qualio in action?

Talk to our team and get a plan built around your regulatory requirements and growth stage.

Book a Demo