CMO's

Since majority of MAH companies are outsourcing manufacturing to CMO’s you are probably the first point of drug production. Although, you are not the one bearing direct responsibilities for compliance, your pharmaceutical clients are and they will ask you to fulfill their exact serialization needs.

Can you continue your work without serialization solution?

Since majority of MAH companies are outsourcing manufacturing to CMO’s you are probably the first point of drug production. Although, you are not the one bearing direct responsibilities for compliance, your pharmaceutical clients are and they will ask you to fulfill their exact serialization needs. In order to continue your successful collaboration with your clients you should be prepared for upcoming serialization. Serialization will affect you in two ways. First of all is the equipment you use; you have to have lines that are able to fulfill serialization needs, but also you have to have system to exchange data demanded by your customer with them. 

Can you have 5 different solutions for 5 different markets?

It is important that CMOs have the capability to meet international requirements, but must also be flexible enough to meet all of the differing requirements of their customers. CMO often needs the ability to be compliant with the different requirements from their external stakeholders and those of different countries. 

Are you thinking about the future?

If we take look in the past and learn from other markets that have gone under serialization, we think that legislation is likely to progress in the coming years. So, for example, it means aggregation/disaggregation will be a standard requirement in all stages of the supply chain.

Can you simplify multi-vendor mix?

With serialization, you have to connect a lot of different competencies, components and functions. We are able to demonstrate the capability to integrate our serialization solution with your existing IT and packaging infrastructure. 

 

 

Solutions

  • CMO's

    Can you continue your work without serialization solution? Since majority of MAH companies are outsourcing manufacturing to CMO’s you are...

    Read More ...

  • Generic and Originator Pharma

    Can I have 5 different solutions for 5 different markets? Most commonly manufacturers are operating on international market and their...

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  • Marketing Authorization Holder

    What are MAH obligation in regards to Serialization? MAHs are, from perspective of regulatory bodies, only legally recognized entities...

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  • Serialization

    Serialization is applying a traceable serial number to a smallest selling item. A serial number must be assigned to each selling item as...

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  • Supply Chain

    Wholesalers in the whole world are obliged to adapt to different regulations and directives, for example EU FMD – Falsified medicines...

    Read More ...

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