10 Small Submissions
No more than 10 Documents per submission
Extensive features including text comparison, data migration, automation, validation and EDMS integration, Freyr SPL-SPM meets the demanding standards of structured product labeling and structure product monograph.
Structured Product Labeling (SPL) & Structure Product Monograph (SPM) are the mandatory document mark-up standards for Regulatory submission of label content, product and facility information, and any subsequent changes to the existing label information in an electronic format.
Freyr SPL-SPM software is enhanced with extensive features like text comparison, data migration, automation, validation and integration with EDMS. We have introduced both on-cloud and on-premises models to help clients in the reduction of implementation time by providing cost-effective solutions for SPL-SPM submissions.
interactive dashboards and reports
strong editor and text comparison
data migration and integration with DMS
automation and validation
text compare and Up versioning the existing SPLs and SPMs
administration of users, roles, FDA SPL data elements and Health Canada SPM data elements, company, and products information
SPL-SPM and supporting documents repository and SPL-SPM versions management
submission life cycle management
bulk SPL-SPM data migration at the time of client site hosting
reduced manual efforts