Regulatory Information Management (RIM)
Get your pharmaceutical regulatory information in order
In the age of digitalisation, a RIM system (RIMS) plays a vital role within life science industry, as a central hub of regulated information, which supports many cross-functional processes, such as manufacturing, R&D, clinical trials, pharmacovigilance, quality assurance, etc.
Your Challenge
Regulatory Information plays an increasingly important role in the life science industry. It allows for complete portfolio oversight, management of details on individual products, including changes, as well as interaction with authorities and third parties.
A Regulatory Information Management (RIM) system facilitates business processes for the collection, organisation (planning), storage and communication of regulatory information.
For pharmaceutical companies, RIMS should play a major role in
providing the right information
in the right format
at the right time
This will enable users to make the right decisions.
The role of Regulatory Affairs is changing to becoming the linchpin of the organisation by taking up a role as the information broker, by supplying information to different stakeholders, both within as well as outside the organisation.
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Having established a single, reliable source of truth in a RIM, allows for automation of processes (generation of product information, signal detection in pharmacovigilance, providing information for batch release, etc.).
Our thinking
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