Regulatory Information Management (RIM) has been saved
Solution
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.
Why Iperion – a Deloitte business
We can support you regardless of the situation during any stage of your RIM journey: selection, implementation and/or optimisation.
We are system agnostic in the selection of RIM systems and heavily focused on translating your business needs during the implementation or optimisation of technological capabilities. Iperion has accumulated experience with all key software vendors in the RIM environment.
Our Solution
Our approach to RIM consists of:
1. Planning & Setup
We provide a holistic approach for your RIM solution, identifying your specific business needs, while taking the technical and regulatory requirements into consideration, such as Master Data Management (MDM) and the use of SPOR.
2. Selection
Based on our extensive experience, we help you to ensure that the User Requirements reflect your organisation’s needs. The fact that we are tool independent, assures you of impartial recommendation.
3. Implementation
Our holistic approach ensures that key success factors, such as: Data Governance, business processes, business reporting, data migration and analytics, take central stage in your RIM implementation.
In addition, we emphasise the importance of future interoperability and automation of data and processes via systems (e.g. ERP, labeling, DMS, eCTD, etc.).
4. Maintenance
We can strengthen and stabilise your data management operations by providing trained experts. Learn more about our managed services.
Our experts have both hands-on experience with RIM systems, as well as with regulatory activities and related regulatory procedures.
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.).
Contact
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