EU IMPORT & EXPORT
apceth Biopharma is happy to assist clients and partners with the import and commissioning of ATMPs into the EU, according to the current European Directives for this type of advanced medicinal product.
We custom design the best solutions, according to the individual demands of our clients’ ATMPs. We are also able to assume responsibility for the final production stages, including
• finalization of the manufacturing process;
• product labeling:
• product release;
• distribution and reconstitution at the clinical site.
apceth Biopharma experienced Qualified Persons ensure the release of the final ATMP, in line with current European Regulations. As this is an absolute requirement for the clinical testing and/or introduction of ATMPs to the EU market and their export from the EU, this is an essential step.
Finally, we use our long experience in regulatory affairs to help our clients pass through the various regulatory stages smoothly and in the shortest time possible.