Regulis saves under threat WDA

Regulis’ quality assurance team resolves serious shortcomings in wholesaler’s distribution practice and avoids wholesale dealer’s authorisation (WDA) cancellation permitting the business to continue to trade.

Situation

Regulis were asked for support when a company found itself facing the strong likelihood of having its WDA withdrawn, following a routine MHRA inspection that found a number of critical, major and minor deficiencies.

Challenge

The Regulis team identified that communication with the MHRA had been inadequate. Following a site visit from our experts it was rapidly discovered that there were many GDP non-compliance issues across a range of areas. These included the suitability of premises, the QMS itself, key procedures, staff suitability and training etc. On the basis of the findings, the MHRA had served notice that the company’s licence would be terminated and hence, the company would not be able to wholesale product and export product overseas as they had been doing.

Solution

We used our broad experience of interacting with regulators, and our contacts to immediately communicate with the Inspectorate Division of the regulatory authority. Employing our extensive quality assurance and GDP know-how:

  • We constructed a corrective action plan which was proposed to the MHRA.

  • Gained MHRA trust and, via the action plan and a commitment to execute it, negotiated an extension to time.

  • Built a robust QMS for the client’s distribution operation including SOP writing, GDP training, inspection support and Responsible Person provision.

  • Closely supported the company throughout the process and delivered a compliant situation.

Benefits

The Regulis QA team delivered:

  • GDP compliance.

  • The possibility of continuing to operate their wholesaling business.

  • Enhancing the client’s reputation with the MHRA.

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