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Serialization

PCI is leading the global market in Serialization. Our dedicated team work with each and every client to understand the requirements, research solutions and provide a bespoke solution based on need.

PCI offers clients Serialization expertise and services that adapt to the needs of their drug product, package configuration, and ultimate market destination. We offer tailored and scalable solutions depending on project scope, supporting a wide range of drug products, from very targeted therapies with small patient populations up to the largest high volume global medicines. This flexible approach extends to our adaptable technologies, providing PCI the ability to support differing regulatory requirements in various countries around the world. PCI supports clients with both integrated Serialization technologies for highly automated packaging, as well as configurable off-line Serialization technologies capable of providing Serialization for almost any package format.

Providing patients with safe and effective medicines requires assurance that the pharmaceutical supply chain has robust security, maintaining the highest standards for safety and regulatory compliance.
Domestic and international governmental regulations have been implemented to help address the global integrity of the pharmaceutical supply chain. Through the use of integrated and multilayered technologies a systematic methodology has been undertaken to combat counterfeit drug products, thereby allowing for validation of the integrity of each drug package delivered to patients.
PCI has implemented a sophisticated network of technologies to provide Serialized drug product for its global clients in this effort. Partnering with clients as they develop and implement their global secure supply chain strategies, PCI provides a flexible and adaptable solution to address each client need. Engaging with leading industry groups such as GS1, expert staff stay ahead of current and future complex Serialization requirements as they continue to evolve for both developed and emerging markets around the world.
PCI has been actively providing Serialized commercial product for both domestic and global markets for many years, enabling a robust understanding of the detailed industry requirements. This industry expertise is further supported through partnership with leading Serialization technology provider Antares, the platform for PCI’s global Serialization services.
PCI offers solutions for a variety of package delivery forms, including primary, secondary, and tertiary packaging, as well as providing a finishing solution for prepackaged medicines simply needing the addition of Serialized codes.
To meet individual market requirements and client preferences, PCI also offers in-line product Aggregation, providing the confidence of structured parent/child relationships amongst the various levels of packaging integration, from primary, secondary, and tertiary packaging to its pallet and captured in the completed batch. This Aggregation solution allows clients to receive a secure and detailed account of their drug product, critical to a safe supply chain.
Mirroring the flexibility of PCI’s approach to Serialization packaging line technologies, PCI’s inbound and outbound secure data exchange in support of Serialization allows clients to utilize and leverage existing EPCIS and ERP networks as part of their individual global strategy. PCI interfaces with client preferred IT architecture, offering a seamless and secure networked data exchange for inbound codes as well as completed and commissioned codes upon batch release.

PCI leverages a true partnership model in meeting the advancing requirements of global Track and Trace. Let our expert and experienced staff help you craft a global strategy for meeting the needs of a safe and secure supply chain.

  • Flexible and adaptable solutions for various package types
  • Best-in-class technologies
  • Multilevel product aggregation
  • Integrated and stand-alone Serialization services
  • Global supply: Expertise in meeting individual country requirements
  • GS1 Compliant
  • Customized services
  • Serialization strategy development
  • Project management
  • B2B system integration
  • Secure data integration and data exchange
  • Package design and development
  • Life cycle management
  • Overt and covert anti-counterfeiting Technologies

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Explore the PCI Process Phase by Phase

PRE-CLINICAL
PHASE I
PHASE II
PHASE III
COMMERCIAL

Swipe to explore the PCI Process

PRE CLINICAL

pre-clinical-icon
  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI Phase 1
  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase I packaging and labelling
  • Storage and distribution

PHASE 2

PCI Phase 2
  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase II packaging and labelling
  • Storage and distribution

PHASE 3

PCI Phase 3
  • Comparator Sourcing
  • Scale Up Studies
  • Phase III Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase III packaging and labelling
  • Analytical testing and stability services
  • Storage and distribution

COMMERCIAL

PCI Commercial Phase
  • Scale up for commercial supply
  • Commercial product manufacture
  • Commercial packaging and labelling
  • Validation services
  • Analytical testing and stability services
  • Product release to market
  • Storage and distribution

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