Project Description

The challenge

A mid-sized global pharma company had a high number of marketing authorisations worldwide and as a result of that they needed a large volume of safety aggregate reports.

The client’s products had been on the market for between two and 70 years, and were a mixture of CP, MRP and nationally-approved products.

However, the department responsible for these safety aggregate reports had limited resources and subject matter expertise. As a result, both the reporting compliance and the quality of the reports was low, and the client needed help to bring these reports up to standard.

Our approach

We analysed scheduled reports against local reporting requirements and found three key ways to make improvements:

  • With regulatory approval, we rescheduled reports which would benefit in DLP harmonisation.
  • Where applicable, we requested waivers on behalf of the client.
  • We reviewed third party commitments and responsibilities, determined the role of reviewers and contributors, and redefined these interactions to make them more efficient.

The result

As a result of our support:

  • The client’s PV writing resources were freed to focus on fewer reports.
  • Compliance and Quality metrics were achieved to a high standard.
  • Process efficiencies were introduced. For example, in defining the roles and responsibilities of reviewers.
““The speed and quality of what they can do is very impressive. One other key strength is their ability to tailor their solution to our needs.”

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