With our competent consultants you can 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.
To be allowed to buy and sell medicines, you need to have a Wholesale Distribution Authorisation (WDA), approved by a competent authority. To achieve that, we offer a predictable process.
The timing of your inspection can be tweaked so you have the approval of your WDA when needed. We can assist you in preparing both for and during the inspection, raising chances of a successful outcome.
Our experienced consultants can help you prepare the documentation needed for the application, as well as give advice on what needs to be in place. If any part of the quality management system is missing, we can assist you in finding a remedy for that.
Among other things, a WDA requires the registration of a Responsible Person (RP) with the competent authority, in accordance with EU Good Distribution Practice (GDP) guidelines.
The Arex quality team has a number of consultants that are experienced RPs, with proven expertise and approved by the competent authorities.
Acting Responsible Person (RP), including 24/7 coverage
Auditing
Evaluation/structuring of distribution system
Quality management system (QMS)
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.
