Qualified Persons (QPs) play a vital role in bringing products, especially new products, to market within Europe. Global clients look to the diverse range of skills and specialisms of our highly experienced team of QPs to ensure their clinical studies not only meet the most rigorous standards but also run smoothly, seamlessly and cost effectively.
PCI QPs have earned the highest credentials in accordance with the European Union standards and requirements. Each is qualified to degree level in Pharmacy, chemistry or biology and continuous professional development ensures understanding of and adherence to legislation impacting operations and clients’ products.
The diversity of experience within our ever-expanding team of QPs means we deal quickly and expertly with special issues and technical challenges right across the pharmaceutical dosage spectrum, from small molecules to biopharmaceuticals and Advanced Therapeutic Medicinal Products (ATMPs).
Our QPs take responsibility for all stages of the compliance process which includes auditing manufacturing facilities anywhere in the world to ensure that each batch has been manufactured in accordance with GMP compliance, as well as certifying products for use in clinical trials and, for registered products, release to market.
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. This service extends to CMC advice beginning with requirements for Active Pharmaceutical Ingredients (APIs) and extends through the formulation process. The amount of data required varies depending on the phase of the clinical trial and strategic advice can be offered to ensure that regulatory expectations are met with a minimum of expense.