Regulatory

Development of drugs and other products for human use (and animals or fish farming), are subject to strict regulatory guidelines, compiled by national and international authorities. Drug development and medical devices are under The Norwegian Medicines Agency, while food supplements and food are under The Norwegian Food Safety Authority.

The EMA (European Medical Agency) has executive responsibility on the European level, and provide guidelines that also apply in Norway. In the United States, both drugs and food are under the FDA (Food and Drug Administration). Regulatory cooperation internationally between the EU, US, Japan e.g., is coordinated by the International Committee for Harmonisation (ICH), which also provides guidelines.

For a product to be developed as a drug, food supplement or medical device, it is most important to understand which guidelines to comply with from an early stage in the product development. We will assist our clients with regulatory challenges, in cooperation with our partners in the Life Science Pilot Network.

Through Life Science Pilot, Catapult Life Science will organise training courses, in order to build regulatory product development competence. See more at www.LSPilot.no

 

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