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.
DSCSA Serialization & Anti-counterfeiting
DEADLINE FOR COMPLIANCE HAS ARRIVED, WE CAN HELP!
We are industry leaders in product security for global medicines with significant Serialization and Anticounterfeiting technologies. Find out how our experienced teams can work with you to understand your exact requirements to ensure your product’s integrity and protect patient safety.
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 QPs 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 QP services include:
- Site audits
- Supply chain management
- Quality oversight
- Release to market
Our QPs take responsibility for all stages of the compliance process including the auditing of manufacturing facilities world-wide 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.