Additional services

Supporting combination product inspection tests and lot releases.

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Combination product development is a complex journey with many potential pitfalls that can cause delays in the development timeline. Being aware of such risks is key to ensuring you hit the market on time with the most efficacious combination product for the patients in need. While the journey is long, we at Zebrasci are here to help you de-risk the many facets of the development journey.

ZebraSci continues to identify opportunities to expand our offering. We understand the Combination Product journey goes beyond some of our featured testing. Rest assured we have experience with many other service solutions and have key partnerships in place to fulfill the needs of our clients.

Additional services include but are not limited to:

Test method development & transfer
Human factors engineering
DHF consultation & support
Combination product development journey consultation

If you need more information, contact us

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Container closure integrity (CCI)

Analytical Testing

Siliconization testing and analysis

Primary container & device functionality testing

Drug combinationproduct design verification

Small scale fill & finish and assembly

Product complaint management & route cause investigation

Combination product incoming to lot release testing

Additional Services

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Select the service/s you request information

Container closure integrity (CCI)Analytical TestingSiliconization testing and analysisPrimary container & device functionality testingDrug combinationproduct design verificationSmall scale fill & finish and assemblyProduct complaint management & route cause investigationCombination product incoming to lot release testingAdditional Services

VIEW CAPABILITIES

Test method development & transfer

ZebraSci can support developing test methods to be used for characterization/verification testing. Our knowledgeable experts will work to understand your testing needs and develop novel solutions to your combination product testing needs
Fixture development and fabrication services are also capabilities our experts offer to support test method development activities
If method transfer is needed, we have the team available to support and ensure that method functions as intended at your designed instrument and site location

Human factors engineering

Zebrasci works with medical affairs experts to develop the comprehensive human factors evaluations,
whether it is a comparative use human factor study, aformative or summative study. We are available to discuss your user needs, your use related risk analysis and combination product or finished product instructions for use to ensure that all your user needs are accounted for during human factors studies.

DHF consultation & support

ZebraSci understands the criticality of effectively managing a Design History File (DHF) and the importance of swift and accurate information being adequately captured during combination product development. ZebraSci’s consulting approach includes a wide range of resources and expertise to support clients throughout the entire product life cycle.

Combination product development journey consultation

ZebraSci understands the complexity of combination product development when navigating through the regulatory space for combination products can be extremely challenging. Our experts can provide guidance on bringing novel products to the market throughout different phases, including new, biosimilar, or generic combination products. ZebraSci can offer advice on implementing risk-based strategies to accelerate development timelines, reduce time-to-market, and conserve samples while maintaining the highest quality standards. Finally, after a combination product reaches the market, our services and support extend to assist clients in monitoring product performance, addressing any adverse events.

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