Time to market: 66% faster.
Client type.
Geography.
Lifecycle stage.
Service area.
Summary.
WDA application support, GDP certificate support, MHRA inspection support, internal audit and creation of a QMS, placement of a QP, preparation of the Quality Manual and Technical Agreement, creation of the Master File.
Having previously focused on serving its domestic market, this leading Spanish pharmaceutical company decided to shift its marketing strategy and expand to the EU. While it already had a few Decentralized Procedures (DCPs) and Marketing Authorization Applications (MAAs) underway in the EU, the organization wanted to expedite the process of its new global strategy.
As using a local UK distributor would only increase costs, the company established an UK affiliate and looked to obtain its Wholesale Dealer License (WDA) from the MHRA. However, the pharmaceutical company had no presence in the UK. It would take approximately 1.5 years before the firm could hire the needed personnel, place an in-house Qualified Person (QP), and develop a complete Quality Assurance system. Facing a dilemma, the pharmaceutical organization turned to Arriello for support in expanding its market and completing its WDA application.
Challenges.
Our client wanted to operate its UK affiliate under its own structure, using its own name, license, resources, and distribution system. At the same time, our client had no prior experience in the UK market. That meant we were responsible for providing guidance every step of the way, from finding a Qualified Person (QP) to ensuring compliant warehouse procedures. On top of that, the need for swift execution left us a short time frame to accomplish significant results.
Solution.
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.
Our efforts didn’t stop there as we guided our client during the MHRA inspection and through to receiving a Good Distribution Practices (GDP) certificate and the WDA(H).
Faster. Better. Smarter.
Arriello’s knowledge, strategy, and execution helped our client successfully accomplish its objectives. Not only did our client pass the MHRA inspection to receive a WDA(H) and GDP certificate, but it also streamlined its global expansion initiatives. Instead of waiting a year and a half, our client experienced success in six short months.
Our faster, better, smarter approach enabled our client to accomplish its vision for market expansion, drastically reducing the to-market time frame and costs.
More Quality Management case studies
View all
