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Dr Regenold GmbH

Dr Regenold GmbH

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Dr. Regenold GmbH is specialised in new product development strategy, regulatory strategy and implementation and market access/go to market solutions. Founded in 1994, we have helped many clients progress their product developments, by providing scientific and regulatory advice through to gaining regulatory approval and marketing authorisation internationally.


We support clients to maximise the value of their asset by recommending development, regulatory and market access solutions to enable them to achieve their milestones or bring their products efficiently to market. Our understanding of the regulatory requirements internationally enables us to help clients design their development programmes to gain regulatory approval in a time and cost effective manner. We are able to do this because our internal team of 50 FTEs is supported by our network, regulanet®, founded in 2001, with geographical representation in over 90 countries and experts who are specialist in certain topics.


We have built our business over many years through recommendation, referrals and repeat business and offer a personalised service where we stay with clients throughout the lifecycle of their project prior to commercialisation.


Our focus over the years has been on medicines and medical devices, following the establishment of our medical device and IVD Company, CE+. Consequently, we are able to offer a unique combination of pharma and medical device/IVD experience which is important in the new era of personalised, more targeted healthcare treatments and solutions. Dr. Regenold GmbH is your passport to Europe.