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We support you with regulatory experience based on firm scientific knowledge. Progress in research and development comes from teamwork, and we are committed to bring the regulatory aspects to the table. By including the regulatory aspects early on in your project, the path to market access can be influenced and time to market minimized. All projects are different and there are rarely any standard solutions to the challenges in product development. Even though regulatory guidelines are for everyone to read, our job is to read between the lines and put the current regulatory thinking in the context of the scientific opportunities in the individual project. We will help you look into the future and predict in what direction the regulation is heading. Welcome for a first contact!
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Pharma
We provide scientifically based strategic and operational support and strong advice to companies and academia from early research throughout the product lifecycle. We provide regulatory and scientific expertise in all areas of drug development.
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Medical Device
As experts in Medical Device Regulation, we support you in developing a clinical development strategy for your medical device, as well as help you develop a cost efficient regulatory plan and build and implement the required quality management system.
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In-Vitro Diagnostics
We have long experience in In-Vito Diagnostic Regulation, and know the requirements when it comes to generating the required clinical evidence. We help you with your IVD device, from clinical development strategy to regulatory plans and implementation.
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