Import, Batch Testing & Batch Release

Import, Batch Testing & Batch Release
Import, Batch Testing and Batch Release
Biological products
Drug products imported into the European Economic Area from third party countries must be released by an European Qualified Person before being marketed
To deal with this issue, Kymos can carry out these activities for human, investigational and veterinary medicinal products . As the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) has extended Kymos Manufacturer´s Authorization by including a new scope for it, Kymos can provide a wide number of services. The most important ones are the method transfer, batch testing of pharmaceutical and biologics, certificate of analysis, manufacturing plant certification of EU-GMP compliance, QP declaration for regulatory purposes, import batches into the EEA, documentary review and batch release.
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Parc Tecnològic del Vallès

Ronda Can Fatjó, 7B

08290 Cerdanyola del Vallès

Barcelona. Spain





+34 935 481 848

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