At PCI we take our clients goals very seriously. When our clients succeed, we succeed.

Our focus is to assist our clients with the management of technical projects common in the Biotech, Pharma and Diagnostic Industries. We strive to combine both technical expertise and project management principles to facilitate smooth successful projects. We can assist clients that require additional staff or expertise in managing complex projects such as shut-downs, facility start-ups and others.

To minimize or eliminate the issues often encountered when companies undertake critical facility start-up /commissioning or other kinds of projects during the lifecycle of a drug/biological product, we strive to ensure across the board understanding and definition of projects steps, deliverables, schedules and roles/responsibilities so that issues during hands-offs are reduced.

At PCI we believe that creating a program that ensures information is generated in a manner that can be used by all disciplines increases the quality of the output while reducing the overall project time and cost to meet its requirements. This is based on the assumption that extensive costs to a project/program are attributed to: 1) redundancy of effort, 2) learning curves at each of the handover points, and 3) changes to the standards at each handover point. A program developed by PCI will minimize these items while maximizing the program throughput and quality.

Our Technical Project Managers have a minimum of 10 years experience and have had formal training in project management. We focus on the implementation of effective strategies while maintaining flexibility and adaptability. Our consultants' tool kit include techniques derived from sound engineering and project management principles.

WE SPECIALIZE IN THE FOLLOWING PROJECT TYPES

  • Facility Start-Up
  • Commissioning and Qualification
  • Validation
  •  Technology Transfers
  • Manufacturing Campaign Start-Ups

We find it useful to share our successes in supporting our clients in helping prospective companies decide whether we are the right partner to trust. PCI provides the kind of technical project management and manufacturing expertise that is needed to facilitate successful technology transfers, process validation campaigns and on-time production.

As one example, for a mid-size company in the orphan drug field we provided technical expertise and leadership support to successfully bring one of our clients urgently needed, life sustaining ‘hard-to-make’ therapeutic molecule to market, under very aggressive timelines. PCI provided technical project management and key technical manufacturing expertise during successful technology transfers and campaign start-ups. We provided strategic leadership and expertise during process validation to address unexpected challenges. Finally, we supplemented regulatory CMC write-up activities. Our contributions were key in the successful launch of this life-saving product and subsequent support. The challenges of shepherding break-through/fast track candidate molecules through the critical stage 2 and stage 3 phases of a product’s life cycle don’t phase us!