QP / RP
Services
Qualified Person and Responsible Person services
with Integrity and Experience.
Qualified Person (GMP)
A QP must not only understand the letter of the law — but the intent behind it: To safeguard public health.
We provide oversight of pharmaceutical batch certification and confirmation, in full compliance with the Marketing Authorisation (MA), EU Good Manufacturing Practice (GMP) and national legislation — covering both human and veterinary medicinal products.
Responsible Person (GDP)
An RP is accountable for ensuring that all activities related to the receipt, storage, and distribution of medicinal products comply with GDP regulations. This includes maintaining a robust quality system, approving suppliers and customers, managing deviations and recalls, ensuring proper documentation and traceability, training personnel, and acting as the key liaison with regulatory authorities — all with the ultimate aim of safeguarding product quality and patient safety.
We provide oversight to ensure full compliance with EU Good Distribution Practice (GDP) guidelines and public service obligations in the distribution of medicinal products.
In need of a (back-up) QP/RP?
We help you gain and maintain trust between you and your partners and competent authorities. With a deep understanding of EU pharmaceutical legislation and based on operational experience, we offer clear, ethical decision-making and a pragmatic approach to complex batch release and distribution challenges.
Let’s work together to protect your patients, safeguard your license, and ensure that every release is done right and unnecessary delays avoided.