Frequently Asked Questions
Our business development managers would be the best to support you through your project needs. To get in touch with one of our managers please feel free to use our Request a Quote website feature on our Contact Us link.
ZebraSci has the capability to support multiple CCI method development projects, with that said it would be totally dependent on the project itself to know if product is needed. To learn more about our CCI development offering please visit our Container Closure Integrity (CCI) page.
ZebraSci has vast amount of experience in this area, please visit our Primary Container & Device Functionality Testing and Drug Combination Product Design Verification capabilities sections to learn more.
Please visit our Analytics page to review our offering in detail.
Yes, please visit our Small-Scale Fill & Finish and Assembly section to see our capabilities around both nFHU and Human use.
Yes, ZebraSci can test both BD and non-BD products. We take data confidentiality seriously and have a legal firewall in place to safeguard our clients’ sensitive information.
Absolutely, ZebraSci is FDA registered and FDA audited with zero observations. We can draft GMP and GDP compliant documents to ensure the highest quality standards for your projects. For Design Verification, we offer a full end-to-end package with GDP/GMP compliant documentation, test method validations, and data analysis.
Yes, we offer consulting services throughout the combination product development journey. Our experienced experts can guide clients through the intricate processes involved in combination product development, de-risking, root-cause investigations, or design verification planning.
Certainly, ZebraSci has an in-house machine shop and a technical development team that can assist with custom requests. Feel free to contact us for more details on how we can support your specific needs.
No, we take data confidentiality seriously, and all project data is strictly confidential. We do not share any data from previous projects to maintain the privacy and integrity of our clients’ information. ZebraSci can only share examples of its own internal studies. However please feel free to review our Case Studies page to see our success stories.
ZebraSci is committed to ongoing research and collaboration within the healthcare industry. We stay updated on evolving technologies and regulatory changes, enabling us to provide clients with the most up-to-date guidance and solutions for their combination product needs. Furthermore, ZebraSci associates attend educational conferences worldwide and knowledge-sharing events to be up-to-date with the most recent updates and industry information.
Yes, ZebraSci is flexible in its approach. We can perform dye ingress testing (probabilistic) to accommodate specific project preferences. Our goal is to meet our clients’ testing needs effectively.