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Regulatory expert insight: Regulatory information management

By Gareth Macdonald

- Last updated on GMT

Tracking “non-content” metadata is an important part of any pharmaceutical submission, yet many drugmakers fail to take an integrated approach to the task according to regulatory expert Kate Wilber.

Regulatory information management (RIM) refers to the organisation of data like, for example, a drug’s approval and launch dates, which can be subject to regulatory scrutiny despite not being a formal part of the document.

Kate explains that while many Big Pharmas recognise that simple spreadsheets are unable to cope with the amount of additional metadata and have developed in-house solutions, smaller drugmakers may lack the resources to take such an approach.

This, she suggests, has driven the rapid growth of the market for outsourced RIMs solutions and has stimulated the development of technologies designed to ensure recorded metadata is clean, organised and fit for purpose.

Kate also shares her thoughts on development of the RIMs market going forward, predicting that cross platform integration will be one of the key drivers.

Next month Kate and I will discus electronic submission and the impact it is having on the pharmaceutical industry.

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