docuvera: Global LABELING
Docuvera Global Labeling reduces risk and optimizes productivity.
Life Sciences companies consume a huge amount of resource and time managing labeling content contained in Core Data Sheets (CDSs), Package Inserts (PIs), and
Summaries of Product Characteristics (SmPCs). Content is often replicated in numerous labeling documents for varying drug indications, dosages and strengths. This results in a huge volume of highly complex labeling that can only
be overcome with complex processes and people. The issues are compounded by strict and evolving rules for the submission of labeling content to global regulatory entities.
Download this data sheet to see where Docuvera fits into your Labeling process.
docuvera: medical information
Rapidly design, build and deliver medical information across all communication channels using Docuvera.
As a global deliverable of Medical Affairs, medical information is used to disseminate trusted clinical and scientific information on drugs and medical devices to Healthcare Professionals (HCP), patients and government regulatory entities. Medical information is distributed through multiple content outputs such as standard responses, FAQs, dossiers and presentation/ speaker decks across a spectrum of delivery channels. The accuracy of these information products is crucial to ensure message consistency and regulatory compliance. Changing regulatory standards and geographic localization challenges introduce significant risk, errors and threats of omission to content that historically can only be addressed by complex authoring processes.
docuvera: FOR REGULATED DOCUMENTS
A single platform to author, review, approve, translate, reuse and publish components of content to regulated documents.
The pharmaceutical industry is dependent on regulated documents to ensure compliance in a highly regulated environment. As regulations change, become more complex and diverse, so do demands on the business to ensure compliance. This makes the development and maintenance of required, regulated documents increasingly difficult. This reality has the potential to expose pharmaceutical companies to a higher risk of compliance failure.