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Batch Release

Each and every batch of a medicinal product used in the European Union has to be certified and released by a Qualified Person.

Delivery to patients takes place only after our Qualified Person (QP) has certified every production batch that has been produced and controlled in accordance with the relevant country legal requirements and any other regulations relevant to the production, control and release of medicinal products.

This certification process, including the European Union Batch Release, applies to medicinal products imported from outside the European Union including batches that undergo labelling and packaging procedures in house. This ensures that the quality of all our shipments complies with the highest possible standards.

We have been inspected and issued the relevant licenses by the Medicines and Healthcare Regulatory Agency (MHRA) to be able to offer these services on your behalf. This batch release service offers companies the option of placing medicinal products with a Marketing Authorization on the market without the need to establish a new or modify an existing Quality Management system or to hire a Qualified Person.

Our batch release services include:

We also monitor contract manufacturing and ensure quality management according to Good Manufacturing Practice (GMP) is being adhered to. Ascenders can help your products to reach markets quickly and safely by supporting you with the monitoring of timely and rigorous testing of your products with complete confidence that all regulatory, quality and safety standards have been met.

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