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Regulatory

Linnea Ingredients are Active Pharmaceutical Ingredients, Purified Ingredients and Herbal Extracts. Two new Technologies, Neosol and NioSkin, have been recently developed for the improvement of the solubility and skin permeability of active compounds and herbal extracts.

The regulatory department is vital to making safe and effective healthcare products available worldwide by working with Federal, State, and local Regulatory Agencies and personnel, i.e. working with such Agencies as the Food and Drug Administration and the European Medicines Agency.

Linnea Regulatory Affairs play a key role in the Quality System ensuring compliance with all pertinent regulations and laws and continuously updating the Drug Master Files (DMF).

DMF represent a fundamental support framework for Linnea’s portfolio of active ingredients and are provided in CTD (Common Technical Document) format in accordance with the technical requirements of regulatory authorities worldwide.

This documentation guarantees the quality of Linnea’s active ingredients as part of the licensing procedure for regulated drugs and traditional herbal medicines.