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Pharmaceutical Serialization and Anti-Counterfeiting

Patient safety and product integrity begins with strategic approach in providing pharmaceutical and biotech products through a safe and secure supply chain.

PCI partners with clients to develop dynamic and multi-faceted strategies for ensuring product integrity, utilizing the latest technologies in product serialization and cutting edge solutions for incorporating anti-counterfeiting requirements for packaged products.

Pharmaceutical Serialization

Evolving legislation within the United States and European Union, along with a patchwork of global requirements, has brought the need for serialization to the forefront of the healthcare packaging market. PCI offers a robust set of serialization services supporting our clients, including consulting on serialization strategy, physical application and management of serialized identifiers within the packaging process, and inbound/outbound data management for packaged product.

Process

PCI’s serialization technologies integrate a diverse portfolio of packaging processes including primary, secondary and tertiary packaging across a wide variety of pharmaceutical and biotech product delivery forms. PCI maintains a flexible approach to technology integration, allowing for ease of changeover and application to each packaging challenge. Data aggregation and code commissioning is administered through cutting edge technologies and secure multi-layered network systems.

Data integration

PCI partners with clients to ensure speed and security in data transfer, connecting technology platforms and ERP systems delivering seamless data integration between systems.

Global standards

We support medicine destined for over 100 countries world-wide. The varying Track & Trace and E-pedigree standards between countries requires a flexible and adaptable solution to product serialization. PCI’s global network offers expertise in meeting individual country requirements, supported by a consistent yet adaptable set of technologies meeting global needs.

Anti-counterfeiting solutions

Successful pharmaceutical serialization and anti-counterfeiting strategies require comprehensive solutions to stay ahead of those who seek to manipulate the supply chain. PCI offers a portfolio of overt and covert anti-counterfeiting technologies, working with clients to establish a strategic and cost effective approach in turn creating an evolving product integrity strategy for the lifecycle of the product.

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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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Our global reach and localized support ensures PCI as a strategic partner remains focussed on delivering speed-to-market and the commercial success of our customers

PCI is a global company that focusses on delivering speed-to-market and the commercial success of our customers

Why choose us...