Regulatory affairs organizations experience significant challenges in managing all the information and correspondence associated with global submissions and product registrations. In many instances, labor-intensive, manual processes are in place, and information is organized in spreadsheets or costly, custom systems.
In addition to these inefficiencies and costs, outsourcing partners need to be managed and the appropriate regulatory filings need to be updated and approved by health authorities prior to implementation of manufacturing change controls to ensure compliance.
Partnering with regulatory optimization experts who know the latest leading industry standards, technologies and process efficiencies at the start of the initiative can help ensure that the best procedures for planning submissions, authoring, review/approval, managing health authority correspondence/ commitments, integrating with change control processes, etc., are implemented.
Achieving your RIM vision: CGI’s RIM framework
CGI has extensive experience working with clinical trial sponsors and CROs to understand their regulatory information management challenges and help them successfully achieve an optimized RIM vision.
We have developed a comprehensive, leading practice RIM framework to facilitate the development of a future state RIM strategy and roadmap for managing regulatory information across the organization. Our framework addresses the people, process, information and technology aspects of the RIM vision, and ensures alignment among executive and business leaders.