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Clinical studies for medicinal plants or natural substances are subject to different conditions than other studies. Phytopharm Research has relevant expertise and experience in this field. We are an audited clinical research organization (CRO) und realize every study design from drug monitoring to randomized controlled double blind studies. Naturally we work in accordance with the GCP guidelines, with three experienced examining physicians and a practiced team in our own clinic.
We give you professionalism every step of the way, from the study concept through trial subject recruitment to the study report and publication, as individual parts or a total package.
Dr. Joerg Gruenwald is our specialist for clinical studies, medical writing & regulatory affairs.

Algae
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You can do a lot of things with algae. An algae product must be registered as a novel food, if it was not already on the market before November 1997. The food industry is being increasingly regulated. Registration as a novel food is comparatively simple, but not without studies. We have a great deal of experience performing studies on novel food products. We know the optimum number of cases, the correct study length and the proper study concept to satisfy the regulatory authorities. |
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Phytopharma-
ceuticals
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The spectrum of phytotherapeutic products is dominated by a few traditional medicinal plants. Due to the lack of patent protection possibilities there is an enormous amount of generic products. There hasn't been a real innovation introduced on the market in years. The possibilities are unlimited.
A simple combination of two well-established plants can be innovative. The only requirement to use this marketing potential is well-performed studies. The effectiveness and superiority of the combination must be proven, otherwise a registration will not be granted.
Medicinal plants can also be those traditionally used in other countries but not known here. These plants offer a fantastic potential when their effectiveness and tolerability can be clinically proven. Studies make the difference.
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You can look into the future
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Your patent protected medication is successful on the market. When the patent expires, generic copies will quickly appear on the market and fight for your position. Instead of standing by and watching your turnover and profit shrink you can take steps to prevent it. New galenic forms or combinations can save your chance for a new patent. We will certainly find promising avenues of approach in your documentation. This way a patented blood pressure medication can be re-patented as a migraine medication for women. |
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