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How It Works?

Keeping Up-to-Date With the Prescribing Information (PI)

Keeping Up-to-Date With the Prescribing Information (PI)

 
 
Managing Electronic Drug Registration Drug Listing

Meeting Various Health Agency Submission Requirements Efficiently

 
 
Notifying Changes and Updates in an Automated Way

Managing Electronic Drug Registration & Drug Listing

 
 
Meeting Various Health Agency Submission Requirements Efficiently

Notifying Changes and Updates in an Automated Way

 
 

SPM Readiness

Health Canada started accepting HL7 Standard XML Product Monographs on a “By Request” basis.

The actual deadline for the transition was ended on July 31, 2020. The transition period was established to enable the industry to be in place for the full launch scheduled for Fall 2020. Health Canada is currently in plan to make the XML Product Monograph (PM) format a mandatory requirement by Fall 2022.

Decode More About XML Product Monographs or SPM.

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Key Differentiators

Dashboards and Reports
Dashboards and Reports
Structured Product Labeling
Structured Product Labeling
Text Comparison
Text Comparison
End-to-End Automation
End-to-End Automation
SPL Validations
SPL Validations
Central Repository
Central Repository
Workflow Management
Workflow Management
In-built Editor
In-built Editor

Freyr SPL-SPM

Aligns With

Health Authorities

Health Authorities

  • US FDA
  • Health Canada

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Industries

Industries

  • Pharmaceutical
  • Biotechnology

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Submission Types

Submission Types

  • 12 Submission Types of SPL (USFDA)
  • Master Template - SPM (Health Canada)

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Client Testimonials​

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 really 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

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

Senior Specialist, 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

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