One of the most significant challenges to the Life Sciences industry is the regulatory content requirements imposed by the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA), individual European member states, and other global regulatory agencies around content provided in submissions. The need to manage Life Sciences content – from the discovery process to documents to ECG and image data - affects the Life Sciences industry on a daily basis with these “watchdogs” constantly looking over your shoulder. A regulated content management system with an audit trail is essential to this effort to create, update, review, approve, and publish – whether in 
paper or electronic form – the required content.
d-Wise has worked with CRO’s, industry and vendors on regulated content solutions from discovery to manufacturing and publishing. Our experience can help you select, install, extend or modify your content management solutions to ensure your systems move beyond the data to meet the evolving global regulatory agency requirements for content management.
d-Wise helps your company by delivering:
- Analysis of a variety of regulated content management solutions clearly outlining the pros and cons of each alternative
- A plan to integrate existing business processes with the selected content management solution
- Processes for “views” of the content and how content can be extracted to meet regulatory operation requirements.
Regulatory Content Management Experience
Designed a pilot project to allow internal users of a top ten pharmaceutical company to use a variety of content management solutions as part of their internal RFP selection process.
Implemented a Regulatory Content Management solution for a large international cigarette company who performs clinical research and is concerned about the potential for the regulation of this industry
Provided strategic direction for a plan to move from current content management solution to new solution within a pharmaceutical company
Worked with a top ten pharmaceutical client to prepare Design, Installation, Operational Qualification, and Performance Qualification documentation to use in selection of their content management solution.
