We specialize in all aspects of licensing herbal products as medicines, food supplements and cosmetics. We advise manufacturers on registration of their products in European, North American and Pacific markets. We offer services ranging from feasibility studies via assembling the registration dossiers and associated documentation for traditional herbal medicines (THMP), well established use (WEU) registrations and full market authorizations (MA). We help manufacturers with placing and establishing their products in new markets, take products through the registration process according to national requirements, assist with setting up a sourcing, contract manufacturing or distribution system or finding suitable distribution partners or businesses suitable for acquisition respectively.
- Ethnobotanical and Ethnopharmacological Plant Research
- Literature Research and Reviews
- Compilation of Plant Profiles
- Medical writing
- Plant Photography
- Tailor-made Content Management
- Translation Service
- Product Development and Sourcing of Raw Materials
- Product Placement, Distribution
- Product Management and Marketing
- Registration of herbal products according to national legislation
- Traditional Herbal Medicinal Products (THMP)
- Well Established Use (WEU)
- Full Market Authorization (MA)
- New Dietary Ingredients
- Food Supplements
- Cosmetics
- Support, guidance and preparation of all regulatory documents in CTD format
- Support, guidance and preparation of Quality Overall Summaries or Clinical Overviews
- Preparation of the Summary of Product Characteristics (SmPC)
- Preparation of patient information leaflets and user testing
- Submission and management of applications
- Interfacing with regulatory authorities
- Support and guidance with all post–approval activities, variations, renewals, PSURs etc.
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