A One-Stop Solution for All Your
SPL-SPM Needs
Ensuring swift implementation and cost-effective solutions for SPL-SPM submissions, Freyr SPL-SPM meets the demanding standards of Structured Product Labeling and Structure Product Monograph.
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.
- A Global Specialty Generic Pharmaceutical Company
accelerate and streamline
Freyr SPL-SPM, Bridging Your Needs with Innovation
Streamline and manage SPL-SPM modifications adeptly, ensuring data accuracy.
Instantly access, assess, and validate SPL-SPM, no matter where you are.
Be up to date with the Prescribing Information (PI). Stay informed with real-time updates and changes.
Meet US FDA and Health Canada requirements efficiently.
Manage Electronic Drug Registration and Drug Listing effortlessly.
Get notified with changes and updates in an automated way.
KEY FEATURES AND FUNCTIONALITY
Simplify and Automate SPL-SPM Submissions
Freyr SPL-SPM aligns with the compulsory Structured Product Labeling (SPL) and Structure Product Monograph (SPM) mark-up standards for electronic Regulatory submissions.
Freyr SPL-SPM provides interactive dashboards and reports, all housed within a centralized repository.
Freyr SPL-SPM facilitates text comparison and up-versioning of existing SPLs and SPMs while maintaining a comprehensive repository for supporting documents and version management.
Hassle-free data migration and integration with Electronic Document Management Systems to efficiently organize and directly access electronic documentation from other databases throughout a project.
Freyr SPL-SPM features an in-built validator, ensuring files align with health agency guidelines and fully comply with FDA SPL format requirements.
Freyr SPL-SPM includes a tracking module for monitoring all stages of SPL submissions and tracking review comments until final approval.
COMPLIANCE AND DOCUMENT MANAGEMENT
Freyr SPL-SPM: Streamline Your Submission Essentials
Comprehensive administration of FDA SPL and Health Canada SPM data elements, company, and product information.
Freyr SPL-SPM’s comprehensive repository helps to maintain the SPL lifecycle efficiently and it also streamlines import of previously published SPL formats into the tool.
Freyr SPL-SPM manages the labeling process, storing change details, including content of formatted labeling, carton labeling, or container labeling using an electronic XML SPL labeling standard.
Oversee every stage of the submission process, from inception to completion.
Hassle-free, bulk data transfers when hosting on client sites.
Freyr SPL-SPM: Compliant, and Tailored for Your Needs
The software adheres to 21 CFR Part 11 and Health Level Seven (HL7) standards for compliant eCTD submissions to various health authorities.
It can be deployed either on cloud or on-premises, which suits all SPL & SPM submission requirements.
Freyr SPL-SPM software has an automated process for new SPL-SPM submissions and revisions.
Freyr SPL-SPM allows users to minimize the time of developing the SPL with its cloning feature.
