Marketing authorization of medicinal products, especially herbal medicinal products, traditional herbal medicinal products, homeopathic products, herbal MedDev Class I and cosmetics with natural ingredients.
Preparation and audit of the dossier and scientific review for herbal medicinal products (quality, preclinical and clinical part). Project planning as well as project coordination, regulatory strategies.
Risk Management Plans for medicinal products, especially herbal medicinal products.
Preparing scientific opinion for herbal food supplements especially for Polish authorities.
Evaluation whether product can be authorized as food supplement or Food for Special Medical Purpose (FSMP) in Poland and EU
Projects and opinions for herbal medical devices Class I, including labelling, justification for use in special groups as children.
Expert opinion for homeopathic and anthroposophic products, including opinions for variation procedures (eg. indications, use in children population).
Preparation of opinion and data for the patent process of natural substances or herbal products, cooperation with a patent attorney specializing in pharmaceutical market.