Inserts, Outserts & IFUs

Custom Designed and Folded Package Inserts, Outserts, IFUs & Booklets

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.

Package Inserts & Outserts

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).

Inserts
- Inserts are folded to meet the tolerances of your automatic inserting equipment for in-line cartoners and blister-packaging equipment
- Additions can also be placed into your healthcare product packaging to create a memorable unboxing experience
- Wafer sealed inserts are an excellent solution for small end-product folds
Outserts
- Applied to bottles during filling operations
- Folded to a variety of finished sizes and styles, such as right turn angle outserts (RTA) or strip-style outserts
- Topsert can be mounted to the top or side of pharmaceutical bottles
- Sidesert can be mounted to the side of pharmaceutical bottles
Married Outserts
- One or more outserts glued together to create a bundle.
- Created by gluing one or more outserts together to create a bundle. The outserts can be a combination of physician and patient information and allows for multiple copies or additional package information.
- Twinserts can be an example of a married outsert by combining PI with medical guides
Onserts & Topserts
- Similar to inserts or outserts but affixed to the packaging

Patient Information and Instruction Documents

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.

IFUs and DFUs (single or multi-language)
- A multi-folded leaflet formed from a single sheet of paper, for insertion into cartons providing space for detailed patient information for single or multiple languages
IFUs with serialized barcodes
- Including a variable data barcode, QR Code or serialized number on an IFU
Medical Device Manuals
- Educational booklets on medical devices, including start-up guides and other materials

Quality and Compliance at the Core

Our facilities are regularly audited and have received ISO certifications for Quality Management. Our uncompromising attention to detail ensures we address your unique challenges while achieving the highest quality and consistency. We deliver precision via:

Our adherence to ISO-certified inspection processes, which include the use of computer vision software to compare printed products against approved customer artwork.
QC-controlled sheet feeding, padding and batch counting
The dedicated work of our operations team – pre-press designers, press operators, folder operators, bindery department, and shipping department – each of whom take pride in the pivotal role they play to deliver essential packaging for our customers and their patients.

We follow cGMP and ISO standards throughout the manufacturing process, and our quality management team ensures that each project is delivered to the customer with the proper documentation and certifications.

Other Products

Your Turnkey Partner for High Quality Labeling and Packaging

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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Introducing RLG Healthcare – Compliant. Responsive. Full Service.

Inserts, Outserts & IFUs

Custom Designed and Folded Package Inserts, Outserts, IFUs & Booklets

Inserts, Outserts & IFUs

Package Inserts & Outserts

Inserts

Outserts

Married Outserts

Onserts & Topserts

Patient Information and Instruction Documents

IFUs and DFUs (single or multi-language)

IFUs with serialized barcodes

Medical Device Manuals

Quality and Compliance at the Core

Other Products

Your Turnkey Partner for High Quality Labeling and Packaging

Markets We Serve

Healthcare

Pharmaceutical

OTC

Medical Device

Biotechnology

Clinical

Contact Info