ROSETTA Papyrus™ is a user-friendly, comprehensive, web-based application that enables real-time access to a broad range of
regulatory information. This includes the regulatory status of products worldwide by tracking the regulatory life cycle of
the product from the time the dossier is estimated to be dispatched through the time the product is approved and launched in a market.
Furthermore, Papyrus enables data entry at various points throughout the regulatory process and provides users with extensive
search and reporting capabilities.
ROSETTA Papyrus™ provides the following benefits:
- Global access to the registration status of any product in any country
- The ability to track the registration process from submission through marketing license expiry date
- The ability to determine where a product is manufactured
- Support for the Periodic Safety Update Report (PSUR), Renewals, and Annual Report Processes
- The capability to search for information by Active Pharmaceutical Ingredients (API’s)
Regulatory Information Management Capabilities:
ROSETTA Papyrus™ provides the management of the following information:
- Medicinal products (product name, country, version, regulated document, medicinal product classification)
- Packaged medical products (packed item, manufactured item, batch identifier, shelf life, storage, data carrier identification, package, physical characteristics)
- Medical devices (device batch identification, device nomenclature, device characteristics)
- Pharmaceutical products (ingredients, specified substance, substances, strength, reference strength, API, route of administration, Pharmaceutical product characteristics)
- Manufacturing (manufacturing operation, medicines regulatory agency, marketing authorization holder)
- Marketing (marketing authorization procedure and application, PSUR, marketing status)
The system provides reporting capabilities for the users that meet the following characteristics:
- The reports are user customizable to allow data to be easily retrieved from the system.
- The reports are generated in Adobe Acrobat PDF format for viewing and printing or in Microsoft Excel format for easy data manipulation.