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A Certificate of Suitabilitydoc is a document required to demonstrate the compliance of a pharmaceutical substance with the requirements of the European Pharmacopoeia.
Any manufacturer seeking to market a pharmaceutical substance in Europe is required to file a Certificate of Suitabilitydoc.
The Certificate of Suitabilitydoc can be filled out online through the website of the European Directorate for the Quality of Medicines.
The purpose of the Certificate of Suitabilitydoc is to demonstrate that the pharmaceutical substance meets the requirements for quality and purity.
The Certificate of Suitabilitydoc must include information on the manufacturing process, control of impurities, and analytical methods used to assess the quality of the substance.
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