ZebraSci Inc.
ZebraSci provides pharmaceutical, biotechnology, and medical device companies with development, manufacturing and testing services. We help our clients overcome their most difficult primary container and drug delivery device challenges. With over 30,000 square feet of laboratory and manufacturing space between our East Coast and West Coast facilities, ZebraSci offers a broad suite of scientifically differentiated services ranging from device technology selection, primary container engineering, device development, verification & validation to stand-alone analytical and physical testing support. Led by our broad experience and collaborative approach, we are committed to finding the shortest, most efficient path to success for you and your team. Our clients partner with ZebraSci to resolve technical issues and accelerate “time to market” to support the development of safe and effective products for commercialization around the globe.
Company details
Find locations served, office locations and our distributors
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
This company also provides solutions for other industrial applications.
Please, visit the following links for more info:
- ZebraSci - Container Closure Integrity Helium Leak Detection
- MicroCurrent - Model HVLD - Container Closure Integrity High Voltage Leak Detection
- ZebraSci - Container Closure Integrity Laser-Based Headspace Analysis (HSA)
- Risk Assessment Services
- ZebraSci - Nondestructive Vacuum Decay Leak Detection Technology
About Us
The Combination Product Experts at ZebraSci are your Partner from Concept to Commercialization
Pharmaceutical, Biotechnology, and Medical Device companies utilize ZebraSci’s combination product development services and innovative inspection equipment to accelerate their time to market.
From small scale pilot plant fill/finish to device assembly to test method development/validation, ZebraSci’s extensive capabilities are a valuable asset to help our clients commercialize their combination products. Once commercialized, ZebraSci continues to provide commercial manufacturing and quality support services such as final lot release testing and complaint management to ensure full product lifecycle support.
The team at ZebraSci is comprised of cross functional teams that are passionate about developing and launching combination products. ZebraSci offers consultation, project management and test solutions throughout the entire product life-cycle; ensuring your product is launched, on time, on budget, and in compliance with ISO 13485:2016 and FDA 21 CFR 820
Our experienced team has provided solutions for drug delivery devices and combination products for nearly ten years. Our cross-functional team is geared to deliver thoughtful, integrated solutions to your device projects. By combining experience, a unique methodology, customized tools and a passion for results, we help our clients produce tangible results from strategy through launch and beyond.
We’re not your ordinary CRO or CDMO – we’ve got you covered from Concept to Commercialization. Let’s connect!
Coronavirus / COVID-19 Essential Business Operation Announcement
ZebraSci is considered an essential business supporting the development and release of pharmaceutical and medical products for the greater healthcare community. We will continue to operate with the safety of our people, our customers, and the communities in which we operate as our top priorities.
Mission, Vision & Values
We help life science companies accelerate combination product development and bring therapies to patients.
ZebraSci is a leading combination product development partner for life science companies. We strive to bring these company values forward in everything we do…
- Treat One Another With Respect: We treat our colleagues and our customers with respect
- Customer Focus: We provide the best customer experience
- Embrace Feedback & Take Accountability: We own the business results, anticipate challenges, and openly accept feedback
- Innovation: We meet challenges by developing creating solutions, improving processes, and applying new technologies
- Lead: We demonstrate our cultural beliefs and actively coach others to do the same
- Quality: We are engaged in our craft and are committed to the development of impactful healthcare products
Commitment to Quality
At ZebraSci, our purpose is to provide clients with accurate, reliable test data using the modern, state of the art equipment that is properly calibrated, validated and maintained. Our staff follows strong adherence to cGMP quality standards and our QMS holds the status of accreditation to ISO / IEC 17025:2017 granted by PJLA. We aim to comply with ISO 13485:2016 and FDA 21 CFR Part 210, 211, & 820 for all of our combination product development services.
Our History
ZebraSci Inc. was founded in 2009 by Robert Schultheis as a company dedicated to developing inspection technologies to ensure quality in parenteral packaging and combination products. Over the years, we’ve grown substantially and by concentrating on scientific expertise, customer service and a strict adherence to regulatory compliance. ZebraSci now works with 100’s of pharmaceutical, biotechnology, and medical device manufacturers. Our clients partner with ZebraSci to resolve technical issues and accelerate “time to market” to support the development of safe and effective products for commercialization around the globe.
Zebrasci - Your Preffered Partner
We are passionate about developing and launching combination products.
Medical Device and Biopharmaceutical companies gain an edge by utilizing ZebraSci. Our technologies, combination product development services and ISO/IEC 17025:2017 accredited testing lab provide the resources you need for your medical device and combination product development project. Whether you require support with flexible engineering clean room fill / finish activities, mechanical performance testing, or container closure integrity testing, ZebraSci can help.
Our experienced team has provided solutions for drug delivery devices and combination products for nearly ten years. Our cross-functional team is geared to deliver thoughtful, integrated solutions to your device projects. We’re not your ordinary CRO – we’ve got you covered from Concept to Commercialization.
Quality
ZebraSci Inc. was founded in 2009 as a company dedicated to developing novel inspection technologies to ensure quality in parenteral packaging and combination products. Over the years, we’ve grown into a service organization by providing scientific expertise, superior customer service and a strict adherence to client requirements. ZebraSci now works with 100’s of medical device, pharmaceutical, biotechnology companies to help them develop combination products. Our clients partner with ZebraSci to resolve technical issues and accelerate the “time to market” of safe and effective products.
ZebraSci, Inc. has developed and implemented a Quality Management System (QMS) to demonstrate our ability to consistently provide products and services that adhere to FDA regulations, ISO standards, and customer Quality System requirements.
The QMS at ZebraSci, Inc. is ISO/IEC 17025:2017 accredited, ISO 13485:2016 certified, and FDA 21 CFR Part 210, 211, & 820 compliant for all of our combination product development services. Along with providing the highest quality inspection products and laboratory services, we will strive to continuously improve our QMS, keeping quality and compliance to applicable regulations at the core of our daily work, and to keep client satisfaction at the forefront of our business. These core values will enable us to lead the industry.
Want to learn more about our medical device and combination product testing and development services? Contact us below to schedule an audit of one of our sites.
Medical Device and Biopharmaceutical companies both large and small partner with ZebraSci. From entrepreneurial start-ups to Fortune 500 companies, our laboratories have the resources and technology you need for your medical device and combination product development project.