Another year has gone by and, as usual, a&r has been involved in amazing projects. We also had the chance to meet former and new clients; we visited trade shows and attended expert events all around the world.

Regulatory services

Substance-based medical device

In the last one and a half years, we have supported several clients with the compilation of their technical documentation for substance-based medical devices under the new MDR regulation, including all necessary test and studies.

Novel Food

When it comes to novel food regulatory support, the novel food expert team has been involved in over 40 novel food projects under the previous novel food regulation (EC) 258/97 as well under the current NFR (EU) 2015/2283. Only in the last two months, we have submitted two novel food applications.

Herbals

Our expert team has also been constantly supporting clients in herbal drug applications. If you are planning a THMP registration in any EU countries or need assistance with any part of your CTD, we are here for you. Get in touch!

CBD

With overwhelming interest and the very positive feedback received from participants, we hosted two regulatory seminars on the current regulatory situation for cannabidiol-containing food products in the EU. The seminars provided an overview of the regulatory challenges that food business operators currently face and explained the requirements for the submission of Novel Food applications for CBD in foods/supplements.

Regulatory webinars

Currently, we are also resuming our activities regarding our interactive free webinars. We hope you enjoy our selection. This month, we hosted the first of this year on substance-based medical devices under MDR – steps you need to take! by our medical device experts Dr. Marlen Landschreiber and Dr. Solveigh Krusekopf. If you are interested in a tailor-made training on any regulatory topic, get in touch.

Clinical services

Our clinical research department has accompanied more than 25 human clinical studies investigating very innovative nutrition and medical device products, conducted either for marketing or regulatory purposes. a&r offers a newly developed quality management approach, which provides exactly those services that are required to deliver high-quality data by reflecting the specific needs and requirements (budgets!) of clients and products.

In one health claim application process, the EFSA panel confirmed that the clinical studies conducted by a&r have shown the claimed effect. Thus, we know how to run studies accepted by EFSA.

Thanks to very precise planning and perfect execution by our clinical operations team, a&r was able to include more than 700 subjects in a cold-and-cough study within 4 months, and this only in the Berlin area. By the way – completely within the previously agreed budget!

In 2019, we were able to expand our expertise in weight management, prediabetics, and infant nutrition. Another growth & tolerance study aiming for more than 300 newborns investigating a new infant formula will be closed in recruitment soon due to a unique collaboration with only 12 (!) efficiently operating clinical trial centers and partners in 3 European countries.

When requested by our clients, we also publish the results of clinical studies conducted by our CRO. Recently, we published the results of 2 clinical studies, one being on effects of aged garlic extract on arterial elasticity using EndoPATTM technology and the other one on the safety and tolerability of cellobiose in healthy subjects. For full information on these publications, click here. Furthermore, we have recently successfully completed one FDA regulatory study, and another one is ongoing.

Licensing and Matchmaking

The a&r MatchMaking Platform, which was launched in 2017 to bring together companies looking for local and worldwide in/out-licensing opportunities in natural health products, has successfully included about thirty new business opportunities in our licensing database featuring premium finished products, branded ingredients, and other technologies. Daily enquiries regarding products offered in the licensing database confirm that the MatchMaking Platform is an excellent strategy for innovation. During the matchmaking process, a&r confidently supported clients by performing technology and product scouting, due diligence, competitive intelligence, market analysis, providing advice on clinical trials, etc. To explore your next business opportunity, please contact Dr. Inês Rocha: matchmaking@a-r.com.

Thank you for giving us the opportunity to support your business and to share with you our unique combination of regulatory and scientific consulting and clinical research expertise in the field of natural health products.

– 31.01.2020

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