Our consultants have the expertise to help you achieve a WDA, allowing for the timely distribution of your products to patients. We can offer a dependable solution to support your organisation with all GDP-related matters, including RP coverage and inspection support.
If you have a wholesale distribution authorisation (WDA), you must register a Responsible Person (RP) with the competent authority, in accordance with the EU Good Distribution Practice (GDP) guidelines. The job of the RP is to ensure that GDP compliance is maintained.
In case your current RP is about to leave, or needs extra support, Arex Advisor can provide this service as an interim or permanent solution.
The RP’s responsibilities include:
Ensuring that the company maintains and implements a quality management system
Record keeping
Setting up training programs
Performing products recalls
Assessing and approving subcontractors and suppliers
Performing self-inspections of the company
The Arex Advisor quality team has a number of consultants that are experienced RPs, with proven expertise and approved by the competent authorities.
We are used to working with many markets, providing 24/7 coverage. Our RPs have experience from setting up the quality function for companies starting up, establishing efficient systems adapted to the client’s needs.
We have an excellent track record of successful WDA applications and authority inspections.
Auditing
Evaluation/structuring of distribution system
Quality management system (QMS)
WDA application management, including inspection support
Input to quality agreements
Management of product quality complaints
Nelly Fransén
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
