Development and approval of the quality certificate template for the manufacturer

Certificate of quality analisis of a pharmaceutical product batch is a document issued by the manufacturer for imported pharmaceutical products certifying conformity of a batch with the requirements of analytical and regulatory documentation or quality control methods established at the time of its registration in Ukraine. Certificate of a pharmaceutical product batch or product must include the summary information in accordance with the requirements to the content. As has been demonstrated by our experience over recent years, certificates don’t have necessary information or some information is frequently missing, so we will help to develop a certificate template that will meet all requirements according to the current legislation of Ukraine.

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    Certificate of a pharmaceutical product batch or product must include the summary information in accordance with the requirements to the content: name of the product; manufacturer’s country and the country of operation; number of the registration certificate; strength of the pharmaceutical product /its activity; dosage form; size and type of packaging; batch number and batch size; date of manufacture; expiration date, etc. We will develop a certificate template that will help you during the process of import or export of the finished product over its life cycle. For more effective cooperation with the manufacturer or representative of the manufacturer, we will promptly inform about changes in the legislation of Ukraine and will draw up recommendations for implementation of these changes in the process of manufacturing.