To help our client reach its UK market objective quickly, we evaluated the working arrangements of our client’s UK entity and of a potential warehouse together with the QP, who then pre-audited the warehouse’s procedures to create a quality system based specifically on the warehouse’s needs.
Together with the QP, Arriello created a further list of recommendations based on the Quality Management System as well as a Quality Manual and the Master File, holding all the client’s Standard Operating Procedures and vital company data.
Next we created a job description for our client’s on-site Responsible Person (RP), prepared a Technical Agreement between all parties, and continued our on-site analysis for an extra two months.
Once we established all the necessary processes and documents for our client’s success, Arriello prepared the WDA(H) application and managed the submission through the MHRA portal.
However, our efforts didn’t stop there. We also guided our client during the MHRA inspection and requested the MHRA audit to finalize our client's application and grant its request for a Good Distribution Practices (GDP) certificate and the WDA(H).