EU GMP required?

We know how ...

In case you want to market your own products within the EU, you need to transfer the respective Marketing Authorization to the EU in first place. You may do this by establishing your own branch office. In this case you can also get support from us to set-up a EU-GMP compliant GMP system for the branch. Alternatively, you may choose our comfort option “Company-As-A-Service” and we take care of the whole MAH transfer for you.

The second step is the GMP-inspection of your manufacturing site. Within our “Inspection-As-A-Service” package we perform an intense pre-audit to assess your GMP-status and propose necessary actions for improvement. Furthermore, we offer to manage the inspection process from application to follow-up.

Contact us

to get your project started.