ZebraSci Inc.
6 services found

ZebraSci Inc. services

Combination Product Development Services

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 monitoring.

Medical Device Commercialization

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 monitoring.

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 sustainable growth. Whether its emerging regulations, latest industry best practices, or regulatory oversight trends to direct strategy, we help customers operate within the new and existing regulations in ways that protect, enhance, and create value. As a trusted business advisor, we work in partnership with our customers to deliver customized, practical solutions aimed at mitigating current and potential risks to the organization.

Testing & Analytical Services

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. Standardized testing per ISO Syringe Testing standards provides medical device manufacturers and drug delivery experts a common basis for producing reliable test results.

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 simplify self administration, reduce patient anxiety and provide improved safety features. Drug Delivery from a well-engineered device is more controlled, delivering a precise measured dose and contributing to overall patient compliance.