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Our strength is your benefit

  • Our approach: Do it right first!

  • We understand hands-on as the consistent application of effectiveness

  • Because you as a customer must be able to derive maximum benefit from my service.

 

  • With a sense of proportion, according to your needs and compliant with the requirements

  • It is crucial to grasp the critical dependencies (critical path) quickly , but not to lose yourself in detail.

 

  • Micro management mostly just absorbs resources.

 

  • Because a little more blur brings more efficiency!

  • By the way: "Being creative" is not synonymous with "being unstructured". 

  • Ensure compliance to ISO 11607

  • Creating the entire packaging system documentation

  • Managing Packaging System Performance testing

 

  • Managing Sterile Barrier System Stability testing

 

  • Packaging System risk assessement according to ISO 14971

 

  • Creating SOPs and Rationales

 

  • Development of forms and templates

  • Be ready for audits & inspection

  • With a smart assessment tool we can investigate gaps in relation to:

    • ISO 13485

    • 21 CFR 820

    • GMP

    • and ISO 9001 (maybe your supplier does not hold an ISO 13485 but an ISO 9001 certificate)​​

  • Supporting the TD packaging part to receive the MDR certificate

  • Sharing best practise

  • Address questions originally asked from the Notified Body​​​

  • Intellectual property is their capital.

  • Please do not underestimate this factor, especially because it has a tax-reducing effect, in Switzerland.

 

  • We work together with proven experts who, can apply the method of providing evidence (Note: The tax authority in Switzerland would like to see it)

 

  • And our expert writes and registers your patent (claim) on paper.

  • Providing guidance to comply with the new regulatory requirements

  • Set up Risk Management Process in conjunction with Usability testing

 

 

  • Smart selection of climate testing conditions

 

  • Rationale to select appropriate performance test conditions

 

  • Set up a smart process validation, e.g. platform approach​​

Temporary work or work on contract

  • bleyco swiss GmbH holds a licences for the professional hiring of services in the form of temporary work or work on contract within Switzerland.

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