ZebraSci is known as a partner in combination product testing and customized engineering studies for some of the world’s top pharmaceutical companies.
We provide
comprehensive solutions to meet our clients’ specific testing needs and guidance in the combination product area.
Our team
consists of highly skilled engineers and professionals who possess in-depth knowledge and experience in combination product testing.
We stay
up to date with the latest industry standards and regulations to ensure that our testing methodologies align with the most current guidelines presented in ISO, USP, or ASTM standards and align with FDA/ EUMDR regulations and recommendations.
Combination products, which integrate drugs, devices, or biological products, present unique challenges when it comes to characterization, testing, and evaluation. At ZebraSci, we understand the complexity of these products and offer a wide range of testing services tailored to address our clients’ specific requirements. Whether a client requires mechanical testing, compatibility/ feasibility studies, DOEs, extractables and leachables testing, or any other unique study, our dedicated team will develop a comprehensive testing plan that meets the specific needs. At ZebraSci, we leverage state-of-the-art calibrated and validated equipment and cutting-edge technologies to deliver accurate and reliable results.
One of our key strengths is an ability to develop custom testing methods and testing plans for engineering studies. Test options include injection-through clothing, mimicking autoinjector powerpack spring force, threshold analysis & non-inferiority (comparative) use studies for custom thresholding studies for Generic ANDA or Biosimilar BLA applicants, as well as Design of Experiments (DOEs) and a variety of root-cause investigations utilizing different tools. We recognize that each combination product is unique, with its own set of characteristics and performance criteria. Our technical and scientific development team can work closely with clients to understand unique product design, intended use, and regulatory requirements.
We support you during the process
Partnering with ZebraSci means gaining access to a library of expertise and knowledge. We are not only a testing laboratory but also a strategic partner invested in our clients’ success. Our team is available to provide guidance and support throughout the entire testing process, from initial consultation, throughout characterization work, to final reporting and successful product launch.
