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Ensuring material safety

Benefit from our long-term experience in material evaluation and toxicological know-how when preparing a Biological Evaluation Plan (BEP) and Report (BER).

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Compliant to MDR & ISO 10993

All device classes and types

Drug-device combination products

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240+

BERs prepared

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800+

materials evaluated

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20

years of experience

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  • Molecule classes
    We can support you with our expertise across the full spectrum of drug development: from small to large molecules, biologics to oligonucleotides and more.
  • Development stages
    TODO
  • Species selection
    TODO
  • Technologies
    e.g. silencing novel approaches?

Abstracting complex documents

Outsource the complete biological evaluation preparation process and profit from a cleanly abstracted process and a well-defined data request interface.

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Better understanding

Discuss your evaluation strategy with our experienced preclinical and regulatory consultants to receive constructive feedback on your plan.

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More insight

Benefit from a comprehensive gap analysis performed by a consultant during the preparation of the biological evaluation plan.

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Fewer lab tests

Avoid unnecessary tests by preparing literature-based toxicological assessments to address gaps in your evaluation.

The practical solution for Class I devices

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Biological risk assessment (BRA)

The BRA serves as a streamlined version of the BER, specifically designed for Class I medical devices to facilitate cost-efficiency while maintaining regulatory compliance. Operating within the guidelines of ISO 10993-1, the BRA focuses on evaluating the biocompatibility of all materials used in the medical device, including its packaging. This assessment scrutinizes the potential biological risks associated with the device's material, such as cytotoxicity, sensitization, and irritation.

  • Molecule classes
    We can support you with our expertise across the full spectrum of drug development: from small to large molecules, biologics to oligonucleotides and more.
  • Development stages
    TODO
  • Species selection
    TODO
  • Technologies
    e.g. silencing novel approaches?

Frequently asked questions

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