An EU-based pharmaceutical company approached us at Integrated Life Science Group with the goal of entering the UK market. To do so, they had several barriers to overcome. They needed to obtain a Wholesale Distribution Authorisation (WDA) from the Medicines and Healthcare products Regulatory Agency (MHRA), a key requirement for trading pharmaceutical products compliantly in the UK. At ILS, our mission is to empower and support companies as they navigate complex regulatory landscapes, break into new markets, and achieve outcomes beyond what they thought possible. This project is an example of how ILS delivers precise, practical and regulatory-focused life science consulting services, supporting organisations through complex compliance challenges to unlock new commercial opportunities.
Our Challenge
The client, a well-established pharmaceutical company operating across Europe, approached ILS for support in navigating the UK’s regulatory landscape post-Brexit. To distribute medical products in the UK, the client needed to obtain a WDA from the MHRA, a process that requires several layers of rigorous regulation, including a clearly defined Quality Management System (QMS), comprehensive procedural documentation, and successful completion of a regulatory inspection.
Although the client had an established operational model in other jurisdictions, navigating the UK’s regulatory environment demanded a deep understanding of MHRA expectations and a highly structured approach. Drawing on our specialised expertise in pharmacy and life science consulting, we provided end-to-end guidance, from interpreting regulatory requirements to building the documentation and systems needed for a successful application.
Our Approach
ILS applied a structured and collaborative methodology to guide the client through each phase of the application process. Central to our strategy was the development and validation of a robust QMS, tailored to MHRA expectations and the specific operational footprint of the client.
We supported the client in producing a suite of clearly defined Standard Operating Procedures (SOPs), covering all critical areas required for a successful WDA application. These included product receipt and storage, temperature monitoring, record-keeping, staff training, and deviation handling.
As with many regulatory procedures, we encountered points where the client considered alternative approaches to documentation. Our team worked closely with stakeholders to ensure that we were aligned on the best route forward, while remaining respectful of our client’s internal workflows and preferences. Through ongoing communication and the provision of clear, evidence-based recommendations, we were able to maintain momentum and keep the application on course.
The Outcome
On the day of the MHRA inspection, the client was awarded their WDA licence number. This immediate result is a testament to the strength of the preparation process and the quality of the documentation submitted.
The licence enabled the client to begin distribution activity without delay, opening a new revenue stream within the UK market and strengthening their regulatory presence across Europe.
Client Feedback
“We’re very pleased with the work done by ILS to help us in obtaining our WDA licence number, opening new commercial opportunities for the business.”
— Country Director
Conclusion
The undoubtable success of this project highlights the value of expert life science consulting in supporting pharmaceutical companies through critical regulatory processes. By combining regulatory knowledge with practical implementation support, ILS helps clients establish compliant operations that enable growth and market expansion.
For organisations seeking to navigate MHRA licensing, implement a new QMS, or expand into the UK market, ILS offers proven experience and a hands-on, collaborative approach.
If you need expert advice on a similar upcoming project, don’t hesitate to get in touch.
