Urgent: Ensure SPL & XML PM Compliance Before July 2025 Deadlines Hit

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Ensure Compliance Before July 2025

The Health Canada XML Product Monograph mandate goes live in July 2025-don’t risk delays or non-acceptance. Freyr SPL‑SPM empowers you to meet these tight deadlines with confidence.

Who It Affects

Pharmaceutical and biotech companies submitting to FDA or Health Canada.

Regulatory, labeling, and submission teams.

Organizations using XML for drug listing, label updates, generics, OTC, or renewals.

Key Requirements

Mandate Deadline:
Health Canada’s XML PM format required by July 2025

Structured Format:
Submissions must conform to validated XML schemas, not PDFs

Compliance Risk:
Non‑compliant files may lead to submission rejection or lengthy delays

Freya Fusion Bot

Your Path to Compliance

  • Audit & Assess

    Identify current PDFs and unstructured monographs

  • Convert to XML

    Automate SPL and SPM tagging

  • Validate Thoroughly

    In-built validation ensures compliance with agency schemas

  • Automate Workflow

    Manage reviews, versioning, approvals using intuitive dashboards

Why Choose Freyr SPL‑SPM?

Freya Fusion Bot

Full XML PM & SPL Support with Built-in Validation

Auto-generate Health Canada-compliant XML Product Monographs and FDA SPL files. In-built validation ensures your submissions align with current schema and guidelines - reducing risk of rejection or delays.

Central Labeling Hub

Maintain a single source of truth across all products and markets. Easily store, compare, and version of monographs and labels - streamline updates and audits.

End-to-End Workflow Automation

Manage reviews, versioning, approvals, and publishing from one intuitive interface. Dashboards provide full visibility, reducing manual effort and reviewing cycle times.

Integrated, Audit-Ready Editor

Edit XML content directly within the platform. Built-in change tracking and audit trails ensure full traceability for regulatory teams.

Seamless System Integration

Connect Freyr SPL‑SPM with existing document management and regulatory systems for consistent, automated information flow.

Automation-Driven Compliance

Automate conversion of legacy formats (PDF, Word) to structured XML. Leverage bulk data migration and cloning tools to rapidly prepare for Health Canada’s July 2025 mandate - while ensuring 21 CFR Part 11 / HL7 compliance.

Freyr SPL‑SPM empowers you to meet tight compliance deadlines, optimize operational efficiency, and future-proof your labeling processes — while reducing manual burden and regulatory risk.

Why Act Now?

Stay Ahead of Deadlines
Avoid bottlenecks and rejected submissions

Maintain Market Access
Keep your product launches on track

Reduce Manual Burden
Lean on automated workflows and error-checking

Future-Proof Labeling Operations
Prepared for evolving global XML standards

What Our Clients Are Saying

 

Thank you Freyr for responding to our extremely pressing issue regarding SPL submissions. Though the requirement was on a short turnaround time failing which the application to the FDA had to be cancelled. You guys have worked it out without compromising. We are extremely happy to see your rapid response in sharing the package to FDA. The entire Freyr team has to be congratulated on being able to provide an important service in a very short period of time. Again, thank you for the unbelievable response to our pressing request.

Associate Director, Global Regulatory Affairs
A Global Specialty Generic Pharmaceutical Company
 

The SPLs looked good. And the response to one of our queries to handle combining/de-listing was also great

Associate Director, Global Labeling
An American multinational pharmaceutical company
 

Thank you so much. We appreciate the work spirit shown by Freyr to get things done whenever required on priority basis.

Deputy Manager, Regulatory Affairs
An Indian multinational pharmaceutical and biotechnology company
 

Freyr is amazing! Thank you so much for your quick work on this SPL. We are extremely grateful to Freyr for prioritizing this submission.

Senior Specialist, Global Labeling
An American multinational pharmaceutical company

Join leading life sciences companies already using Freyr SPL‑SPM to stay compliant and ahead of regulatory deadlines.

Don’t risk delayed or rejected submissions - request your demo today.

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