Players in the natural health market must be up to date with the latest regulations or they'll suffer the consequences, legally and economically. Berlin-based clinical research organisation and consultancy firm analyze & realize is on hand to help navigate the red tape, explains managing director Dr Volker Spitzer.
Dr Volker Spitzer: The regulatory landscape has changed dramatically, while consumers have become much more engaged in their own health management. At the same time, scientific knowledge around the power of nutrition and natural health products has flourished.
There has also been a shift in healthcare from treatment to prevention, encouraging stakeholders to think in a different way about health and disease. This has created strong momentum for natural health products, supported by annual market growth rates of more than 7% - this is around 4% in the pharmaceutical industry.
As a consultancy and CRO, it is crucial that we are always on top of the latest regulatory, scientific and consumer innovation trends in order to support customers successfully. In times where regulatory hurdles are getting tougher, it is also necessary to think outside the box and identify creative - but legally valid - solutions.
With more than 1,000 customers and over 300 clinical trials, we stand out in the consulting and CRO business as a 'one-stop innovation shop', analysing and realising the potential of our clients' products.
Our team is always on top of the latest regulatory requirements and will find the best strategies in the jungle of novel food, herbal medicine, medical devices, EFSA health claims and food supplements. For more than 20 years, we have been an instrumental part of the development of many well-known products in the industry, with a turnover of several hundred million euros, and have also supported smaller and mid-size companies to help them achieve success in the market.
Our own clinical trial centre in Berlin is highly specialised for working with natural health products, and is able to recruit volunteers for a broad range of indications.
With a team of around 35 people plus our international network, we are optimally equipped to handle a broad spectrum of customer requests, and we are well prepared to support the industry in the future. With our flexible mindset, we always dare to identify a business collaboration model that best fits the needs of our customers. This can be based on typical pay-for-service agreements or collaboration models with shared risk approaches.
The major issues are certainly around regulatory challenges and product differentiation in the market. Typical topics are linked to complex novel food regulation, the low probability of achieving EFSA-approved health claims, current legal limbo with functional botanical claims and restrictions around medical devices - for instance, positioning probiotics as medical devices is prohibited under new regulation.
We are working on a range of different health areas and, over the past 20 years, we have always adapted to trends and market needs. Currently, our clinical trial centre in Berlin is working on projects around weight management, immune health, gut health, mental health, heart health and metabolic health. On top of that, we are expanding into new areas such as healthy ageing, men's and women's health, and physical performance.
The latest addition to our portfolio is a licensing matchmaking service, where we help our customers identify licensing opportunities for licensees and licensors dedicated to the natural health product industry. Not only do we help bring the interested parties together, but we also support the complete deal process as needed, including due diligence and regulatory checks.
We have also started our own webinars to inform clients on hot topics in regulation, science and innovation around natural health products.