Life Sciences: Regulated Secondary Packaging
Regulated secondary packaging specialist for medical device, pharma, and biotech manufacturers. Over two decades of US-based, multi-site production experience: folding cartons, IFUs, labels, and cross-border solutions. All built on validated processes and compliance-first operations.
Secondary packaging for regulated life sciences: folding cartons, IFUs and DFUs, labels, and expansion labels. We don't compete on primary sterile containers or shipping materials; we specialize in the secondary packaging and regulatory documentation that carries your product through the supply chain and into the hands of end users. Design, print, finishing, and fulfillment from US locations, with US-Mexico cross-border logistics support.
Multi-layered compliance stack built on ISO 9001, cGMP-aligned operations, and active CAPA, with document control, supplier qualification, and internal audit across all facilities. Consistent process control: 0.004% DPM baseline over a three-year period. We understand your validation timelines and ASL qualification requirements. Compliance is not an afterthought at KP; it is embedded in how we operate.
Warehousing and logistics hub in Pharr-Reynosa, with established routes serving the Otay Mesa-Tijuana, El Centro-Mexicali, and Mariposa-Nogales corridors. KP serves manufacturers with operations on both sides of the border without increasing supplier overhead. Proven methodologies ensure your packaging moves seamlessly from our line to your manufacturing floor, often eliminating the need for secondary first-article inspections. Single partner, unified compliance, integrated scheduling.
Customized inventory management that aligns with your production schedule, not against it. We manage replenishment at or near your facility, eliminate procurement touchpoints, and provide real-time lot tracking and forecasting. Our team monitors consumption patterns and proactively adjusts supply, so you can focus on manufacturing, not inventory planning. Reduces your inventory risk, unplanned line shutdowns, and supply chain administration. Flexible across multiple SKUs and production scenarios.
SOC 2 Type 2, ISO 27001, and HIPAA-compliant infrastructure protect your product data, manufacturing records, and compliance documentation. 21 CFR Part 11 controls ensure the integrity of electronic records and signatures across your supply chain. Data is protected through encryption both at rest and in transit, supported by role-based access controls and complete audit trails. Annual third-party audits validate the controls that protect your packaging data and regulatory records from cybersecurity threats, unauthorized access, and compliance risks.
Streamline supplier management, simplify compliance oversight, and reduce the time and resources required for validation activities with KP. Whether you need high-volume carton runs, quick-turn digital labels, or VMI replenishment across multiple SKUs, a single KP relationship oversees it all.
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