Serialisation - Implementing falsified medicine legislation

Serialization became be mandatory in February 2019.

We provide qualified, independent consulting and hands-on support in initiation, update and implementing corresponding processes in your QM system - based on your internal processes, current requirements and your products.


This includes:

  • Professional review of your entrepreneurial- and QM situation
  • Hands-on partner for on-boarding
  • Advice and support in the selection of suitable serialization software reflecting your needs
  • Creation and / or updating of your SOPs, e.g. market release, release for sale, verification, complaints or recalls
  • Implementation and training of processes according to the organizational requirements
  • Partner in uploading or de-registration of serial numbers on your behalf
  • Supplier qualification
  • Implementation of projects to improve the QM system and GxP processes
  • Monitoring compliance

Please feel free to contact us.

We are looking forward to give you all the strategic and operational support you require.

 

 

 

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