Leading pharmaceutical and biotech companies trust ADDEV Materials Healthcare to produce their clinical trial booklet, tamper evident and commercial labels to the highest quality standards. Our highly efficient and well-equipped facilities are ISO 13845:2016 certified, FDA registered and compliant to cGMP CFR 210, 211, and 820.
Safety, precision, and regulatory compliance are critical components when it comes to pharmaceutical manufacturing and packaging activities. Our expertise in flexographic and digital printing and precision die cutting allows us to transform high-performance materials into custom labeling and packaging solutions that meet the stringent requirements of the pharmaceutical and clinical trials industry.
Utilizing advanced flexographic and digital printing technology, our highly trained experts know how to print and die-cut a wide variety of pressure sensitive labels, including product information labels, vial and syringe labels, bottle labels, thermal transfer labels, and other packaging labels.
At AMH, we work with world class material suppliers to source a diverse range of label materials to fit your application needs. Whether your label application requires pharmaceutical grade paper, film or adhesive, we can source it.
As a long time manufacturer of clinical trial and booklet labels, we understand that clinical trial labels require a high level of quality control and management to ensure stringent regulatory requirements and controls are met.
At ADDEV Materials Healthcare, we invest in the latest inspection software and advanced printing technology to provide our customers with the highest quality product, every time.
Our vast range of capabilities allows us to provide our pharmaceutical customers with a variety of clinical trial label options, including:
Numerous pharmaceutical label applications require labels that can adhere to surfaces effectively at below freezing temperatures. As a preferred converter to many leading material suppliers, we have access to highly technical materials engineered specifically for cryogenic storage applications and have the capabilities in house to customize the size, shape, and print, depending on your application needs.
Extended content labels (ECLs) are designed to address labeling challenges in the packaging industry. They offer the ability to display additional information beyond what is typically included on a standard label, without taking up extra space. Not only does this allow you to provide more information for consumers but also allows for compliance with regulations.
As an expert in manufacturing extended content labels (ECLs), we have a wide range of customizable capabilities, including:
Our Printing Capabilities and Quality Regulations for Pharmaceutical Applications
As your pharmaceutical labeling partner, we ensure all labels are meet regulatory requirements, including ISO 13485:2016 standards and FDA approved specifications. We are your one-stop solution, with the capability of bringing the art, to part:
Advanced technology: ADDEV Materials Healthcare continues to invest in state-of-the-art printing and converting technology for precise and consistent results. Learn more about our capabilities here.
Material compatibility: We collaborate with leading flexible material manufacturers to offer a wide range of medical grade materials, including adhesive tapes, foams, foils, fibers, and nonwovens suited for the healthcare market.
Custom solutions: Our team of experts are here to help bring your custom products to life by providing technical support for material selection, product design, and process development; through engineering and validation, to full scale manufacturing.
Regulatory compliance: Our facilities are ISO13485:2016 certified, FDA registered, and cGMP compliant. At ADDEV Materials Healthcare, we operate in class 7 and class 8 cleanrooms, ensuring the highest quality and safety standards for medical and personal care products.
Call us 262.255.6150 or send a message to sales.amh@addevmaterials.com TODAY to connect with a specialist about your custom product.
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