Profile
PCI is a leading global CDMO, providing integrated end-to-end drug development, manufacturing and packaging solutions to increase product speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of supply chain healthcare services.
With 30 sites across Australia, Canada, North America, the UK and Europe and over 4,300 dedicated employees, our mission is to bring life-changing therapies to patients. Leading technology and continued investment enable us to deliver development to commercialisation solutions throughout the product lifecycle, collaborating with our clients to improve the lives of patients globally.
Services Overview
Drug Development and Manufacturing Solutions
PCI are experts and innovators offering full service formulation development including in-house analytical development services for both sterile and non-sterile dosage forms. Our scalable development and manufacturing capabilities for tablets, capsules, gels, ointments, liquids, sterile dosage forms and lyophilised drug products aid delivery of life-changing therapies to patients from early phase clinical trials through to commercialisation.
Clinical Trial Services
PCI provides a global service with localised focus, delivering over 200 protocols a year in over 100 countries, utilising best-in-class technologies combined with our experienced and dedicated teams. Providing a seamless service, PCI supports the global supply of investigational medicines with pharmaceutical development, clinical drug product manufacturing, packaging, labelling, storage and distribution and full returns service.
Commercial Packaging Services
With true customer focus and flexibility at the core of our commercial packaging services, we are able to support the unique requirements of each product type and global market supplied. Utilising state-of-the-art packaging technologies, we provide advanced primary, secondary and tertiary packaging solutions for a diverse portfolio of conventional dosage forms including oral solids, powders, liquids, creams and gels, as well as specialist injectable and parenteral delivery forms including vials, cartridges, prefilled syringes and auto-injectors. PCI is a strategic partner and an integral part of the supply chain as the bridge between life-changing therapies and patients of our global customer base. Our expertise combined with market leading technologies means we deliver more than just a service, we are a trusted partner sharing an industry-leading depth and breadth of knowledge.
Analytical Laboratory Services
PCI offers in-house laboratories providing a range of analytical services to support clients in the development, clinical and commercial supply of medicines globally.
Our state-of-the-art analytical facilities feature best-in-class, fully GMP and ICH compliant equipment enabling our teams to perform ID testing and analytical method transfers, through method development and validation, to global product release and ongoing stability testing ensuring 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 the capabilities to work with Schedule II-IV controlled substances.
QP Services
Qualified Persons (QPs) deliver a vital role in bringing new products to market. Our highly experienced team ensures that clinical studies not only meet the most vigorous standards but also run smoothly, seamlessly, and cost-efficiently.
Our team of qualified persons assume responsibility for all stages of the process, safeguarding patients including the audit of the supply chain for GMP compliance in addition to certification of products for use in clinical trials.
At PCI, our QPs also offer a consultancy service to ensure that operations are in-line with all relevant EU directives and other necessary regulations.
Storage, Distribution and Returns
PCI offers over 30 years of experience in the Pharmaceutical Storage and distribution of clinical trial materials, effectively storing and distributing thousands of patient kits to over 100 countries worldwide.
At PCI, we work with clients to develop a flexible and dedicated service to meet the needs of each and every clinical trial, irrespective of size or global requirements. Dedicated teams of logistics experts ensure complete accountability and supply chain integrity throughout the clinical lifecycle.
Clinical supplies are stored in facilities dedicated to investigational medicines meeting GMP requirements combined with a full collection, storage, returns and reconciliation of patient supplies ahead of ultimate client requested destruction.
speedsolutions™
PCI is proud to introduce speedsolutions™: a phase-appropriate service offering which combines value-added services and expertise, delivers an integrated approach to every client project, and de-risks the supply chain by eliminating the need to outsource to alternative suppliers.
Wherever you are in your drug product lifecycle, from development to commercialisation, speedsolutions™ provide ultimate flexibility and customer-centricity to support your unique journey. Our solutions are tailored specifically for you, with the sole aim of increasing your product’s speed to study, patient, approval and commercial launch.