5 services found
ZebraSci Inc. Services
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Medical Device Commercialization
ZebraSci’s Services, Resources, and Facilities support development at any stage in the product life-cycle.
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Regulatory Submission Support Services
As competition and increased regulation drive innovation, collaboration between partnerships in a global environment becomes critical to the success of medical device commercialization. We provide pharma and biopharma leaders with insights to reduce regulatory risk and remain compliant, while evaluating strategic tasks against proven strategies that can help align the organization’s regulatory strategy and operational strategy allowing for ...
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Combination Product Development
ZebraSci’s experience in primary container engineering, human factors, and medical device commercialization for auto-injectors, needle safety devices and novel drug-device systems assists organizations in developing combination products – from early concept through commercial launch and post-market ...
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Testing & Analytical Services
Informed & Independent – ZebraSCI has an extensive portfolio of Testing Programs for various packaging and delivery systems to meet the needs of pharmaceutical, biotech and medical device manufacturers. Our experienced team can guide you through test method selection, development and establishment of acceptance criteria to meet regulatory expectations. Selecting packaging components, delivery systems or packaging materials? We’ve seen it all. Offering informed and independent guidance, customers can work with ZebraSCI through each and every phase of the product lifecycle. We’re proud of our open, honest and consultative approach. Rest assured, we have the understanding and capabilities our customers need to ensure efficiency, reliability, and safety, from concept to commercialization.
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Primary Container Characterization
One of the many variables that contribute to drug delivery device reliability is the primary container itself. With our experience with the containers and components from the world’s leading manufacturers, we can assist you with selecting the right components or optimizing your device to an existing container. Leverage our knowledge, experience and partnerships to be well informed for your next primary container ...
Standardized Syringe Testing
The medical device community is continually faced with the challenge of providing patients with reliable solutions for drug delivery. One of the “go-to” delivery platforms are syringes. Glass or plastic syringes are often used in connection with Luer fittings for injection needles, adapters or transfer devices. Another common syringe platform is pre-filled syringes, filled with a fixed dose of drug product in a combination product. ...
Drug Delivery Devices
Drug delivery devices come in many forms from the proven PFS to sophisticated auto injectors and needle free systems. ZebraSci actively invests in the testing capabilities and engineering expertise required to evaluate the new drug delivery systems continually coming to market. Needle based injection systems (injector pens, auto injectors, multi-dose systems) are becoming more common as they provide benefits over manual injection systems. They can ...