Life Science Regulatory Information Management Solutions Reviews and Ratings
What is Life Science Regulatory Information Management Solutions?
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Features of Life Science Regulatory Information Management Solutions
Mandatory Features:
Health authority interactions: Management of HA meetings, correspondence, commitments, questions, requests and responses — all content and interactions
Regulatory content: Management of all regulatory submission content, including authoring, review and approval of submissions content, design history files (for medical device submissions) and archival of eCTDs
Product data management: Tracking product detail, data standards and governance, and the mastering of product data in a repository shared by RIM solutions
Registrations: Managing product registrations in multiple regulatory markets
Product content: Management of all product content, including product labels and promotional material required as part of regulatory filing from life science commercial systems
Regulatory requirements: Tracking of regulatory agency requirements, including the use of analytics tools or services to manage updates and perform impact analysis
Dossier development: Development of the content plan, the distribution for use in multiple regulatory market submissions and the tracking and archive of the plan
Submission production: The forecasting, planning, tracking and production (content assembly, navigation, publish, review and dispatch) of the regulatory submission in a given market