FDA Quality and Regulatory Consultants (FDAQRC) begins Qualified Persons (QP) services. “We are adding this service to our product line to enhance client compliance and assist in product release efficiency for UK and EU drug releases, “said company president Chris Rush.
CEDAR PARK, TX - APRIL 2024 – FDA Quality and Regulatory Consultants (FDAQRC) begins Qualified Persons (QP) services. “We are adding this service to our product line to enhance client compliance and assist in product release efficiency for UK and EU drug releases, “said company president Chris Rush. The QP service offering is for clients who are looking to import pharmaceuticals or medical devices into the United Kingdom (UK) or the European Union (EU) or are based in the UK and EU.
“Adding a Qualified Persons service allows FDAQRC to maintain long-lasting relationships with our clients. Our new service is a testament to our commitment to supporting our clients through every stage of the regulatory compliance process, ensuring their products are safe and effective,” Rush explained.
A Qualified Person is responsible for certifying that the final batch of a drug, drug ingredient, or medical device is following EU Good Manufacturing Practices (GMP) before it is imported and put to market. During the review process, QPs will check batch-specific data and ensure the company’s quality systems and processes meet industry standards.
To be considered a QP, qualified individuals must have significant experience working in the pharmaceutical manufacturing industry. Additionally, educational courses, an assessment, and registration are all required to become certified.
FDAQRC plans to integrate their global consultant network for the new QP service. With over 500 active consultants, FDAQRC will provide experienced and highly qualified QPs who are well versed in the UK and EU’s regulatory compliance requirements. QP consultants will be vetted by FDAQRC and expertly chosen for each client’s individual project needs.
Clients of FDAQRC can expect a streamlined process by simply adding the QP service to an existing agreement, rather than starting an entirely new contract.
To better support clients and consultants through the QP process, FDAQRC will also be opening an office in Northern Ireland.
“FDAQRC is dedicated to being at the forefront of supporting healthcare innovation worldwide. We are excited for a new opportunity to expand our global footprint,” said Rush.
Find out more about FDAQRC’s full suite of services at www.fdaqrc.com.