Excellence From Concept To Completion

Our Clients

KPC International has been in operation since 2001 and since then we have worked on some of the largest Life Science projects in Europe across the Pharmaceutical and Biopharmaceutical industries. We have also successfully completed projects with some of the the industry leaders in the Life Science sector.

We have a global reach. To date, we have delivered projects throughout Ireland, Europe and the US. Our experienced team of in-house experts allows for the support for complex projects as well as having the on-site personnel to manage the location services.

 

Key Projects

Large Biotechnology Start-up Facility

Introduction of Biotech to an existing portfolio

KPC International led a complete managed service of a project drug substance biotech start-up facility to an existing portfolio of a large pharmaceutical company in Eastern Europe. We managed and executed the C&Q Phase of the project and provided significant guidance & support on the Tech Transfer. We also provided extensive support in the areas of Quality & Compliance and Operational Readiness.

Biopharmaceutical Client

Audit finding instigated project to assess the validation status of current and legacy equipment to determine revalidation requirement.

KPC International led a Compliance Assessment against Corporate Quality Standards, FDA 21 CFR Parts 210 & 211 and Annex 15. Remediation activities were then planned, managed and executed.

Construction Client

On the Pre-commissioning and C&Q for the construction of a new facility antibiotic manufacture.

KPC International Senior Consultant’s and Commissioning Engineers provided strategy and guidance. Documentation and execution support provided by our Project Manager and 2 Junior Commissioning Engineers.

Biotechnology client

KPC International provided guidance and mentoring, strategies and documentation to team’s engaged in multiple Tech Transfers & New Product Introduction.

Contract Manufacturing Organisation

KPC International reviewed our clients Cleaning Validation strategies and procedures. We advised on improved strategies and documentation as well as guidance on how to instigate a New Product Introduction Program.