Discover Freyr Digital.
Simplifying complex regulatory functions with software for life sciences companies-powered by
15+ years of hands-on regulatory services excellence.
15+ years of hands-on regulatory services excellence.
Key Challenges & Our Solutions.
Challenges
Freyr Digital Solutions
Lack of version control and audit-readiness in document management.
Effortlessly manage documents, control versions, track statuses, and maintain full audit trails - all in one place.
Manual, time-intensive eCTD submissions are prone to errors.
Efficiently Create, Validate, and Manage eCTD Submissions.
Formatting complexities and validation requirements.
Validate SPL files automatically with built-in checks that ensure full compliance with FDA format and health authority guidelines.
Why Choose Freyr Digital?
Proven Regulatory Heritage
Built on over a decade of hands-on global consulting experience and more than 100,000 submissions managed, our solutions embed industry best practices every step of the way.
Built on over a decade of hands-on global consulting experience and more than 100,000 submissions managed, our solutions embed industry best practices every step of the way.
Global Reach & Proven Adoption
Trusted by 200+ customers, 3,350+ users across 20+ countries, our solutions have been battle-tested in diverse regulatory environments.
Trusted by 200+ customers, 3,350+ users across 20+ countries, our solutions have been battle-tested in diverse regulatory environments.
Customer-Driven Customization
Our highly configurable workflows put your processes first-so you get a platform that adapts to your needs, not the other way around.
Our highly configurable workflows put your processes first-so you get a platform that adapts to your needs, not the other way around.
Flexible Deployment & Integration
Deploy on-premises, in your cloud, or hybrid-with an API-first architecture and legacy connectors to slot seamlessly into your enterprise ecosystem.
Deploy on-premises, in your cloud, or hybrid-with an API-first architecture and legacy connectors to slot seamlessly into your enterprise ecosystem.
Core Modules &
Top Features.
Streamline your eCTD submissions
Inbuilt eCTD validator & viewer
Supports all major eCTD templates
Deploy on-premise or in the cloud
Enterprise-grade document management
Version control & audit-ready traceability
Role-based access & advanced search
Collaborative authoring workflows
SPL (FDA) & SPM (HC) content management
Interactive dashboards & workflow management
Automated validation & submission
Advanced text comparison tools
Freyr Digital Helps…
Streamline Your eCTD Submissions
Streamlining submissions has never been easier. With our electronic Common Technical Document (eCTD) software, you can effortlessly assemble and submit your regulatory paperwork electronically, minimize manual errors, maintain adherence to electronic submission standards, and enhance the efficiency of your submission workflow.
Optimize Document Management
From creation to archiving, manage all your regulatory documents efficiently with our Document Management System (rDMS) solutions. Improve document traceability, ensure compliance with document control requirements, and reduce manual efforts.
Streamline Your SPL-SPM Labeling & Monograph Management
Automate structured labeling and monograph workflows—cloud or on-premise—with built-in HL7/21 CFR 11 validation, version control, audit trails and seamless EDMS integration. Supports all major SPL/SPM regulatory standards worldwide (including FDA and Health Canada).
Modular & Scalable
Use the modules you need today, expand as your needs evolve.
Purpose-Built for Life Sciences
Designed for pharma, biotech, medical devices, and consumer health companies.
Freyr Digital vs. Other Solutions
| Features | Freyr Digital | Other Providers |
| Response Time | 15 minutes | 24 hours |
| Ticket Cost | Free | Charged per ticket |
| Support Model | Three-degree prioritization | Ad-hoc, no prioritization |
| Workflow Flexibility | Customer-driven, highly configurable | Tool-centric, fixed workflows |
| Deployment Options | Cloud/On-Prem/Hybrid | Usually single option |
| Integration | API-first, legacy connectors | Limited or costly integrations |
| Custom Reports & Dashboards | Included | Premium add-ons |
| Compliance Certifications | ISO 27001, 21 CFR Part 11, GDPR-ready | Varies; often extra charge |
Proven Impact
