qualified person (QP) services

Every organization in the life sciences industry is required to have a current and compliant quality system to ensure the safety and quality of all products and services. Quality assurance involves upholding the desired level of quality in your products throughout every stage of the process, from production to delivery to the patient.

At ProPharma, our quality assurance professionals enhance your internal capabilities to ensure the consistency and safety of products. Our team acts as an extension of your Quality Unit, utilizing a hands-on and risk-based approach to quickly improve quality and compliance while implementing practical solutions for your organization.

Companies that intend to manufacture or import medicinal products in the EU and UK require a Manufacturing and Import Authorization (MIA) license and a designated named Qualified Person (QP) to oversee the product quality throughout the supply chain. Acting as an extension of your organization, our QP consultants bring a deep understanding of GMP processes. They work with your team to ensure compliant manufacturing and/or importation of products in the EU and UK markets. Our global team of certified QPs have broad experience covering multiple types of formulations, complex supply chains, technical transfer projects, aseptic/sterile manufacturing, radiopharmaceuticals, biologics, ATMPs, and supply for clinical trials.

To procure, sell and distribute medicinal products in the EU and the UK markets you need a Wholesaler Dealer Authorization (WDA) and a Responsible Person (RP) named on the license. In the UK a WDA can also be utilized to import QP-certified medicinal products from the EU. In that case, you would need a Responsible Person (import). The RP is tasked with supervising the quality of the company's wholesale operation and takes on the primary responsibility for ensuring compliance with GDP regulations and maintaining the quality of the distributed products.

Our highly experienced RPs can act as contractors named on your, or a third-party's, WDA for both human and veterinary medicines under EU and UK Guidelines. If you are new to the EU/UK market we can help you in navigating the road from QMS build, through the WDA application process, a successful inspection, and obtaining your very own WDA license.