Qualified Persons (QPs) play a vital role in bringing 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.
The diversity of experience within our ever-expanding team of Qualified Persons ensures we deal quickly and expertly with specific 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 including the auditing
of manufacturing facilities worldwide to ensure batch manufacture in accordance with GMP.
The team ensure certification of 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, clinical stages and commercial launch of products.