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Transforming Regulatory Affairs

Drive faster time-to-market and greater precision with global submission processes to simplify & reduce work and cost

RIM

RIM on the CARA Life Sciences Platform™ provides a powerful foundation of regulatory information, managing data to make it easy to identify and re-use across the organisation. This consistent global information flows in and out of your processes, making you more efficient.
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RIM on the CARA Life Sciences Platform manages information aligned with data standards as well as your organisation's global product information. 

 

These data power the end-to-end RIM processes, from planning and triggering new submissions to capturing authorisations and corresponding with health authorities.

 

These data also provide context to regulatory authoring, driving the collaborative creation of submission content plans globally.

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Medical device manufacturers need their own regulatory, quality & safety management platform

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Medical device & pharma manufacture are not the same

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Japanese Pharmaceutical Group Kyowa Kirin Selects the Generis CARA™ Life Science Platform