Why do you need an EU GMP certificate?
The EU GMP Certificate is the door to the European Market. Without it there is no chance of any sales in the European Union.
The European Union is now recognized as one of the most important international drug market. Because EU member states recognize the result of the GMP inspection of another EU member state mutually, and they also share the result with Japan, Australia, America and Canada, the influence of EU GMP certification is becoming more and stronger.
>>EU GMP certificate database<<
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How can you get the EU GMP certificate?
It is not easy to get this EU GMP certificate. It requires large investments into systems, procedures and people.
The main procedures of applying for an Inspection by an European Authority are :
1) to become an entrusted manufacturer of an European pharmaceutical company.
2) to apply for an European MA (Marketing Authorization) in EU.
3)to export your products to the EU by an European import company.
What can we do for you?
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- find a suitable European company for you.
- provide you with an existing MA in EU or help you get a MA.
- apply for an Inspection conducted by a European authority.
- provide you with the main documents, validation and logbook templates.
- guide and assist you to do the defect rectification, and ensure that you can achieve the standards of EU GMP requirement.
- provide you with on-site translation support and technical support, while the inspectors are implementing the on-site inspection.
- help you with replying the official deviation report given by the inspector.