The FDA is committed to ensuring that patients will always have access to “clear, concise, and necessary” information. That declaration means that having highly-standardized, printed materials – including package inserts, outserts, onserts, IFUs, DFUs and other regulated materials is simply not optional. You also need to account for these materials with serialization and exact counts and manage version control and obsoletion tightly. RLG Healthcare has the expertise to solve your unique packaging challenges and more. Our facilities have achieved ISO – including ISO 15378:2017 for primary packaging materials for medicinal products – and cGMP certifications to give you independent verification of our compliance with recognized standards.
RLG Healthcare has the expertise to solve the challenges you face when it comes to including required product information in your packaging. We understand that every square inch counts. We also understand the importance of manufacturing to a high standard of quality. We work closely with you to design the proper printing method and fold sizes. This often depends on where the product will be attached to your primary packaging.
With precision printing, our team produces large format 200+ panel PIs, and our folding equipment folds down to as small as 1.125” x 1.125” for a perfect fit on top of your medication bottle. We offer both spot-gluing and wafer sealing to make lock those tight folds in place. We offer in-line gluing and paper banding for when you need to have multiple folded sheets connected together.
RLG Healthcare offers solutions to meet your unique application, including Patient Information Leaflets (PI), Patient Package Inserts (PPI) and Patient Medication Information (PMI).
When it comes to producing essential printed products that contain valuable information for patients whose contents are mandated by law – you need a partner you can trust. Each project is customized to your requirements and designed to integrate seamlessly into your manufacturing supply chain. This process begins with optimizing layout of artwork, to maximize the printing quality and efficiency and ensure important features such as barcodes are optimally positioned to fit your final packaging lines. We offer features such as variable data barcodes, QR Codes or serialized numbering that can make your packaging more dynamic and secure.
Short turns, small runs, clinical trials, product launches and global distribution – yes we do that! RLG Healthcare makes it possible for you to move as quickly as you need to when your product information needs to change. We apply the same strict standards to every project – big or small – so start talking to us today about your next project.
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