Easily meet demanding labeling documentation timelines.
Efficiently developed and accurate labeling documentation is critical in meeting drug development timelines and avoiding compliance violations. Docuvera’s component authoring improves efficiency by reusing approved, compliant blocks of content from the CDS down to the regional and local labels and across other downstream regulatory documents.
Increase productivity, while reducing compliance risk.
Life Sciences Labeling documentation is complex; involving specific guidance for different document types, a range of local Health Authority requirements, varied formatting requirements for submissions, etc. Pharmaceutical companies consume a huge amount of resources and time managing labeling content contained in Core Data Sheets (CDSs), Package Inserts (PIs), Medication Guides, and more. Content is often replicated in numerous labeling documents for varying drug indications, dosages and strengths. This results in a massive volume of highly complex labels that can only be overcome by an untold amount of processes and people. The issues are compounded by strict and evolving rules for the submission of labeling content to local health authorities. Docuvera simplifies and improves the efficiency and speed of creating and managing these complex regulatory documents through the entire end-to-end process.
Robust, collaborative, and easy to use
A scalable enterprise-level LCMS solution built for writers, curriculum developers, and SMEs in a collaborative environment.
Engage learners with responsive, adaptive, eLearning & microlearning
Create and manage large volumes of learning content easily and securely
Localize and translate content by the word, not the document
Reuse content within and between courses, saving time and money
Collaborate and review in real time with course developers and SMEs
Deliver interactive courses for every device with truly adaptive HTML5 publishing
Write once, publish everywhere
