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EU-GMP

You want to offer your pharmaceutical product on the EU market? As a manufacturer, you need a corresponding certification, which you can obtain by passing a GMP inspection for your production facility. To clarify your GMP status in advance, DASCOLI offers you a pre-audit. In a detailed audit report, we list all deficits so that you can work on them before an actual GMP inspection – or approach the inspection with confidence. If desired, we can also accompany the complete inspection process, from the application to the post-processing.

Are you still thinking about, how to market your product in the EU? We are happy to assist you – no matter which route you choose:

Your own distribution company

We help you build a quality management system that is compliant with EU directives. Moreover, we support you in obtaining EU approvals for your products.

Partnership with DASCOLI

We would be happy to discuss the possibility of including you as a supplier in our existing portfolio. We can as well fully support you in this process.

Handling of regulatory affairs

Before you can launch your pharmaceutical product on the market, you need the corresponding authorization to ensure the safety of your product. For a successful registration process, a wide variety of issues need to be taken into account: from planning the overall strategy, to preparing and analyzing data from different fields, to submitting the dossier to the authorities.

 

Market authorization is not a one-time affair:

Even after receiving a market authorization, there are specific regulations on packaging and advertising materials or measures to take in the event of unexpected side effects, that must be complied with. We support you with our services in all relevant matters.

 

We are the right partner for EU-GMP.

Do you need an EU GMP certificate? We know how to get it.