The manufacture and distribution of pharmaceuticals are regulated down to the last detail by national and European regulations. Agreements with manufacturers, logistics providers or service providers are a mandatory part of the quality management system of every pharmaceutical company.

 

Since every company has special features that must be reflected in contracts, the use of standard contracts is of only limited help. Only the combination of knowledge of the operational procedures in the production and distribution of pharmaceuticals and the knowledge of regulations to be taken into account in each case leads to appropriate contracts. We support you, for example, in the formulation of:

  • Delimitation of Responsibility Agreements ( VAV )
  • Safety Data Exchange Agreement ( SDEA )
  • Individual contracts with responsible persons (QPPV , information officer etc. )


Based on many years of experience, we help you with the individual formulation of the contracts and we also support you with the implementation of the contract contents in your quality management (QM) system. Without taking your employees away from other projects and without time-consuming familiarization with legal texts, your QM system will be inspection-proof.

And with every change in legal requirements, we will again be at your side to ensure that your QM system always remains up-to-date.

 

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