Challenge

A clinical stage biopharmaceutical specialist needed support with its regulatory due diligence activities.

Solution

We assembled an expert team comprising an ex-quality assessor who had previously worked in the biologicals unit at the MHRA (primarily on EMA-centralized procedures), and an ex-Senior Director and ex-Medical Advisor for a biotechnology company.

The team reviewed all correspondence with regulatory authorities to identify any red flags that needed to be addressed. This included:

• reviewing proposed validation plans for a new manufacturing process and assessing suitability for MAA using a centralized procedure
• reviewing the package used to support two of their products
• reviewing clinical data for one of their vaccines to assess suitability for a new centralized procedure using a well-established use dossier
• identifying any other major deficiencies in the dossier that may prevent an MAA using the centralized procedure