Medical Affairs - phyguard®
The professional handling of safety information concerning plant-derived products — whether pharmaceuticals, foodstuffs, medicinal products or animal nutrition — requires medical and toxicological expertise, regulatory know-how and outstanding knowledge of all aspects of herbal product quality. Our experts provide you with a holistic evaluation of your existing and future products.
The standards for the risk/benefit assessment of phytopharmaceuticals are constantly changing. Due to an increasingly restrictive regulatory framework and a highly competitive market.the benchmark for product-related efficacy and safety data is higher today than ever before.
Identifying risks and fully realizing potential
We draw on our expertise and exhaustive research to identify the potential of your herbal and plant-based medicinal products, foodstuff or animal nutrition and coordinate studies on efficacy, function and safety in collaboration with recognized testing institutes and experts.
We create expert reports (CTD modules 2.4-2.7, 4, and 5) for the marketing authorization/registration of herbal medicinal products, texts for packaging materials, summaries of product characteristics (SmPC), and instructions for use. We also coordinate readability user tests. In addition, we can provide expert support in cases of complaints, renewals, appeals or legal actions.
A comprehensive medical/toxicological evaluation is also required, for example, when submitting novel-food applications in the case of foodstuffs and for phytogenic additives in animal nutrition.
The phytochemical complexity of herbal preparations means that special know-how is always essential. With PhytoLab, you are in the best of hands.
Research and development
The development of a new product, whether a pharmaceutical, food, animal nutrition or medicinal product, starts with its design. We can support you all the way to realization: from the scientific rationale for active-substance selection and technological form to toxicological evaluation and testing, to planning pharmacological or clinical studies.
Risk management starts with product design
We conduct a comprehensive search of the literature in scientific databases to identify potential risks — such as contaminants or potentially toxic ingredients — right at the outset of our customers’ projects.