PCS offers interim Responsible Persons for product release in the EU.
For Pharma & Biotech
The Responsible Person, abbreviated as RP, is mandated by the EU GDP regulations. The Responsible Person is responsible for most Quality affairs within the company. These responsibilities include; maintaining the Quality Management System, performing recalls, ensuring staff is trained and deciding on the fate of returned products (amongst others).
The Responsible Person is contracted or employed by the warehouse or trader of medicinal products. Although there is a financial relationship, the Responsible Person is independent. Decisions on releasing products from the warehouse, return or quarantine should not be corrupted by commercial motives.
With sufficient experience and formal training you are allowed to be a Responsible Person. The GDP lists a few requirements to become a Responsible Person:
The first step is to get in touch with us. Go to our Contact to submit a request. You can also use the form below to submit a request.
After you have submitted your request, we will plan a telephone conference to discuss your needs in detail.
After the telephone conference we will explore our immediate network of consultants to find you the right Responsible Person. We will organize a meet & greet with each candidate to see if there's a match.
When there's a match in terms of experience and personality we will send you an offer. Once the offer is approved the QP needs to be trained on your products and procedures. Simultaneously we will start working to add the Responsible Person on your wholesale license.
As soon as the Responsible Person has been added to your license, he/she can assume responsibility over the products and the quality system.
We are a pharmaceutical consultancy dedicated to quality and patient safety. Are you looking for a Responsible Person or other interim staff? We have the expertise and network to provide you with highly responsible candidates.
Feel free to contact us if you have any questions about our Responsible Person services or GDP in general.