Serving the Pharmaceutical Industry's Management
in Quality Systems for 30+ years
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PCI is Karen Ginsbury’s company. A UK trained pharmacist with an Msc. degree in Microbiology, when I left industry in 1994, I became a consultant. I have been involved in setting up, maintaining and continuously improving Pharmaceutical Quality Systems.
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Quality is my passion. I believe in minimizing waste, and the way to do it is DIRFT: Do It Right First Time.
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PCI has worked with large pharma, virtual companies with fewer than five full time employees and mid-size companies, to get them through Pre-Approval Inspections (PAIs). We have conducted mock-inspections and mopped up after disastrous regulatory inspections. We have conducted hundreds of audits, for API vendors, CMOs, CDMOs and contract testing facilities. We don't believe in "getting ready for inspection." Our values aim for a PQS with a goal of "always inspection ready."
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We offer pharma, biotech, ATMPs, API manufacturers, wholesalers and distributors, help in fixing problems. We enjoy doing so.
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PCI’s work and client base are handled in a discreet and professional manner.
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Our Services
PCI offers a range of Quality System and GxP consulting. We specialize in inspection readiness, inspection handling and writing responses. We work with our clients to achieve and maintain a constant state of control.
We tailor our services to the exact needs of your company. We work with you to define what these are. By matching expectations, we ensure satisfaction.