Keeping product information current in one country is challenging enough. Life sciences companies marketing products in multiple countries face even greater challenges, including keeping pace with evolving standards for multiple jurisdictions and maintaining overall consistency.
Many life sciences companies are implementing global labeling solutions to manage labeling content and submission, for FDA's SPL (Structured Product Labeling) standard in the U.S. and to meet requirements under EU 726/2004 Article 57(b) in Europe.
Implementing these XML-based labeling requirements presents daunting challenges.
- How can you collect, organize, and track submission status of all existing product information for all procedure types in Europe?
- How can you reduce the time and effort required to format labeling content as required by the FDA and EMA?
- How can you update and manage product information in multiple languages throughout the product life cycle, accurately and efficiently?
Virtify has the answer
Virtify helps you address all of these challenges with web-based software products that enable you to manage labelling content and submissions standards quickly, efficiently and cost-effectively.
Virtify European Labeling and Virtify SPL dramatically simplify the process of implementing the European and US labeling standards. They streamline the management and exchange of product information through a collaborative, structured content management platform that is fully aligned with the regulatory standards.
Virtify Core Data Sheet enables you to centralize, streamline and organize the management and dissemination of core safety and labeling information, reducing the risk of delays and errors.