About Freyr SUBMIT PRO
Freyr SUBMIT PRO is a submission management software from Freyr Life Sciences that supports regulatory submissions for the life sciences industry. It provides document management, workflow automation, and compliance tracking so organizations can manage their submission processes effectively. The software helps teams collaborate on submissions, maintain version control, and ensure compliance with regulatory guidelines. With its reliable features, users can reduce the risk of errors and improve submission timelines. Key capabilities: document management workflow automation compliance tracking collaboration tools version control Best for: regulatory affairs professionals that need to manage and simplify their submission processes efficiently.
Freyr SUBMIT PRO is a top-tier eCTD submission platform designed for the pharmaceutical, biotechnology, and life sciences industries. It combines automation, compliance, and intelligent validation to make regulatory submissions faster and more accurate. By adhering to global standards such as CFR 21 Part 11 and EU GMP Annex 11, it ensures that submissions meet the strictest compliance requirements. With over a decade of expertise and more than 100,000 submissions completed, Freyr SUBMIT PRO is recognized as one of the most reliable tools in the regulatory landscape, outperforming many of its competitors. The platform’s interface is user-friendly and minimizes the need for lengthy training. It includes a built-in intelligent validator capable of detecting up to 800 types of errors in a single check, ensuring submissions meet FDA and other health authority requirements. Its touchless submission process and automated publishing workflows streamline repetitive tasks, allowing regulatory teams to focus on strategic work rather than manual preparation. The comprehensive eCTD viewer offers complete visibility into submission structures, making reviews and edits more efficient.
Pros & Cons
- +Strong compliance with global regulatory standards
- +Intelligent validation reduces submission errors
- +Seamless integration with eDMS platforms
- +Automated workflows save significant time
- +Proven track record with over 100,000 submissions
- −Higher price point for advanced packages
- −Tailored enterprise pricing may lack transparency
- −Integration details with some platforms not publicly listed
- −May require stable internet for cloud features
- −Focused primarily on pharma and life sciences industries
Features
Key features
- Intelligent Validator Tool – Automatically checks submission compliance against regulatory guidelines to reduce errors.
- Touchless Submission Process – Fully automated publishing workflow requiring minimal manual intervention.
- User-Centric Design – Intuitive interface reducing training time and complexity.
- Comprehensive eCTD Viewer – Provides complete visibility into submission structures.
- Automated eCTD Publishing Workflow – Streamlines repetitive publishing tasks for faster turnaround.
- Compliance Integration – Ensures alignment with CFR 21 Part 11 and EU GMP Annex 11 standards.
- Efficient Document Reuse – Enables reusing validated documents for multiple submissions.
Additional features
- eCTD Creation & Validation – Facilitates quick creation and compliance validation of submissions.
- Regulatory Compliance Adherence – Built-in checks to meet FDA and EU requirements.
- Integration with Leading eDMS – Connects with enterprise document systems for seamless workflows.
- Submission Tracking & Management – Keeps all submission timelines and versions organized.
- Automated Publishing – Reduces manual publishing steps through automation.
- Easy Data Migration – Simplifies transfer of data from legacy systems.
- Comprehensive Viewer – Detailed review of submission components in one place.
- Role-Based Access – Manages permissions and security effectively.
- RPA & NLP Technologies – Improves efficiency and reduces manual processing.
- Global Regulatory Support – Handles submissions across multiple health authorities.
Pricing
Annual plans
Submit Pro Geo
USD 4,125
≈ USD 343.75/mo when billed annually
≈USD 343.75/mo when billed annually
Submit Pro Assist
USD 26,400
≈ USD 2,200/mo when billed annually
≈USD 2200.00/mo when billed annually
Countries & Languages
Available in
Interface languages
Billing currencies
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About Freyr SUBMIT PRO
Freyr SUBMIT PRO is a submission management software from Freyr Life Sciences that supports regulatory submissions for the life sciences industry. It provides document management, workflow automation, and compliance tracking so organizations can manage their submission processes effectively. The software helps teams collaborate on submissions, maintain version control, and ensure compliance with regulatory guidelines. With its reliable features, users can reduce the risk of errors and improve submission timelines. Key capabilities: document management workflow automation compliance tracking collaboration tools version control Best for: regulatory affairs professionals that need to manage and simplify their submission processes efficiently.
Freyr SUBMIT PRO Details
Freyr SUBMIT PRO's In-App Market Place
Does Freyr SUBMIT PRO have an in-app market place?
Yes
How many Mini-Apps in the marketplace?
1
Mini Apps
NA
Pricing Options
Plans
Annual plans
Submit Pro Geo
USD 4,125
≈ USD 343.75/mo when billed annually
≈USD 343.75/mo when billed annually
Submit Pro Assist
USD 26,400
≈ USD 2,200/mo when billed annually
≈USD 2200.00/mo when billed annually
Accepted Payment Currencies
USD ($), EUR (€), GBP (£), JPY (¥), AUD ($), CAD ($), CHF (Fr), CNY (¥), SEK (kr), INR (₹), SGD ($), HKD ($)
Pros & Cons
- Strong compliance with global regulatory standards
- Intelligent validation reduces submission errors
- Seamless integration with eDMS platforms
- Automated workflows save significant time
- Proven track record with over 100,000 submissions
- Higher price point for advanced packages
- Tailored enterprise pricing may lack transparency
- Integration details with some platforms not publicly listed
- May require stable internet for cloud features
- Focused primarily on pharma and life sciences industries
Freyr SUBMIT PRO's Support Options
Email Address
contactus@freyrsolutions.comContact
+1 908 409 5626Documentation
https://www.freyrdigital.com/white-papersChatbot
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