PIs, Medical Guides and IFUs

Provide critical information with expert-level printing, folding, and fulfillment solutions.

Printed inserts are a critical component of pharmaceutical marketing packaging for a wide range of medical and consumer products, providing essential usage details while meeting strict regulatory requirements. Prescribing Information (PIs), Medical Guides, and Instructions-for-Use (IFUs) all require accurate printing, compact folding, and efficient distribution to support product launches and consumer product education.

Hatteras specializes in high-volume insert production, printing tens of millions of inserts annually for pharmaceutical, medical device and consumer product manufacturers. Our state-of-the-art printing and folding technology allows us to produce inserts in various formats and sizes, ensuring compliance, durability, and seamless integration into marketing and packaging workflows, backed by on-site warehousing, just-in-time fulfillment, and custom web portals for ordering and inventory tracking.

Custom-Printed Insert & IFU Solutions

Hatteras offers comprehensive insert printing services to meet your exact specifications.

Prescribing Information (PIs)

PIs are a required component of pharmaceutical marketing, detailing dosage guidelines, safety information, and regulatory disclosures. Our production capabilities allow us to print and fold PIs at scale with precise formatting for easy readability. We accommodate multi-language printing, lightweight stocks for cost efficiency, and hundreds of folding configurations to fit different end-uses for marketing collateral, patient starter kits, and packaging.

Medical Guides & Patient Information Leaflets

Patient education is critical in pharmaceutical and medical device industries. We print medical guides and patient information leaflets with high-quality, efficient processes. Lightweight stocks offer affordability for bulk distribution, while custom formatting and folding allow for easy inclusion in product packaging, prescription kits, and healthcare provider materials.

Instructions-for-Use (IFUs)

Many consumer products require clear, step-by-step instructions to ensure proper usage. Hatteras produces IFUs with high-resolution printing, detailed technical illustrations, and compact folding options. We create durable, regulatory-compliant instructional materials that meet FDA and ISO standards while integrating seamlessly into consumer packaging.

Our High-Volume Printing & Folding Capabilities

With PIs, medical guides and IFUs requiring specialized printing and folding equipment while meeting strict compliance standards, Hatteras delivers solutions that balance efficiency, accuracy, and quality.

Our INSERT Capabilities

Specialized Printing Equipment

Insert printing requires a balance of efficient manufacturing and high-quality imaging, while meeting FDA compliance standards. Hatteras’ specialized, high-quality offset printing equipment achieves this balance through continuous roll-fed printing with variable, in-line cut-offs to minimize paper waste and reduce costs.

Advanced Folding Equipment

PIs, medical guides and IFUs must be folded precisely to fit within a wide range of end uses–from pockets in product literature, to patient starter kits, to consumer packaging. Our fleet of insert folders enable hundreds of folded sizes, micro-folding for ultra-compact inserts, and multi-panel configurations to meet regulatory requirements and packaging constraints.

On-Site Warehousing & Just-in-Time Fulfillment

Pharmaceutical companies require ongoing inventory management to maintain a steady supply of printed inserts. Hatteras provides secure warehousing for long-term storage and just-in-time replenishment solutions to stay aligned with clients’ fast-moving needs.

Custom Web Portals for Ordering & Inventory Tracking

Managing pharmaceutical inserts across multiple SKUs and distribution points requires seamless logistics. Hatteras offers custom web portals that allow clients to:

Place orders for new insert production or reorders.
Track inventory levels in real time.
Generate reports to analyze usage patterns and optimize supply chain efficiency.

Inserts