Batch certification and confirmation of medicinal products
Batch certification and confirmation of medicinal products in accordance with the requirements of EudraLex Vol.4 – Annex 16. Based on the customer needs, we provide this service, both for products imported into the EU or manufactured in the EU.
Import of medicinal products into the EU
Import of medicinal products into the European Union in accordance with customer requirements and EU GMP legislation.
Re-test of medicinal products in the EU
We provide re-testing of medicinal products imported from non-European countries in the European Union. We use the services of our contract laboratories.
Testing of medicinal products according to customer requirements
We provide testing of medicinal products according to customer requirements. We use the services of our contract laboratories.
Transfers of analytical methods
For new and existing products, we are able to ensure and manage the transfer of analytical methods to one of our contract laboratories, including verification of non-transferred methods, before the first re-testing of medicinal products according to customer needs.
Development / validation of analytical methods
For new and existing customers, we are able to ensure the development / validation of analytical methods in one of our contract laboratories according to customer needs in accordance with GMP legislation.
Stability studies
We ensure the deployment and management of stability studies of medicinal products in accordance with customer requirements and GMP legislation. We are able to ensure the evaluation of stability studies, including the evaluation of tranches and the preparation of stability reports according to customer requirements.
Expert. to analytical tests
We provide an assessment of analytical tests, proposals for suitable analytical solutions and comprehensive expertise in the field of analytical chemistry in pharmaceutical practice from the perspective of QC according to customer requirements. This type of service is solved in the form of an individual approach to individual customer needs.