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Analytical and Laboratory Services

PCI features fully audited, in-house laboratories in both our European and North America locations offering a range of analytical services to support clients in the development and commercialization of new medicines.

Staffed with expertly qualified analytical chemists, trained and accredited in the most comprehensive laboratory standards, we provide a complete range of resources and responsive services at each stage of the product lifecycle across a wide variety of dosage forms.

Our state-of-the-art facilities feature best-in-class and fully GMP and ICH compliant analytical equipment enabling our teams to perform simple ID testing and analytical method transfers, through method development and validation, to EU product release and ICH stability testing, ensuring data reliability and regulatory compliance.

Our facilities also include HEPA filtered air

handling systems for the analysis of cytotoxic, teratogenic and uncharacterised products, a darkroom for the analysis of light sensitive products, and have the capabilities to work with Schedule II-IV controlled substances. All our services are offered on a stand-alone basis or in conjunction with our clinical, commercial and QP services to facilitate a seamless transmission through the drug development cycle.

Our laboratory services include:

  • Method Development
  • Method Validation
  • Analytical Testing
  • Stability Storage and Testing
  • Import Testing
  • Microbiological Testing

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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...