Sciformix’s labeling managed services provides you with a proactive approach spanning Commercialization to Adverse Event Labeling process (CAEL). It combines Sciformix experts, LEAN processes and automation capabilities that addresses the shortcomings of existing labeling processes and delivers consistent high quality labels in a shorter turnaround time. As an end–to-end labeling management service, our platform comprises a core labeling engine along with our labeling and regulatory affairs experts who act as an extension of your team and ensure delivery of high quality labels compliant with the appropriate regulatory requirements. By employing LEAN methodologies we help you streamline processes, enhance collaboration and delivers efficiency.
Our managed service platform enables labeling project management, from project definition and initiation stage to artwork completion. The communication module allows you to invite multiple stakeholders into the process and acts as a central touch point for all the information and communication. It also allows you to set and enforce timelines for the labeling cycle, depending on regulatory, market and internal requirements. As a centralized system, the platform facilitates seamless integration with your existing legacy tools, and allows you to access, distribute and archive all project related documentation; thereby providing easy tracking and follow-up and a full audit trail. The customizable project information form allows you to construct labels as per regional specific regulatory requirements. Multiple standard style guideline templates, like Quality Review of Documents (QRD) and Physician Labeling Rule (PLR) for EU and US are included, allowing you to auto populate the templates, and conform to style and format requirements.
Unique request IDs are created to tag and manage other child requests and can be linked to dependent labels/countries. Our technology platform detects and maps CDS changes to all applicable LPDs, as part of the same project file and allows you to manage non-English language LPDs as well through a reporting and analytics dashboard.