To help a clinical stage biopharmaceutical specialist company in its regulatory due diligence activities, Alacrita assembled an expert team comprising an ex-quality assessor who had previously worked in the biologicals unit at the MHRA (primarily on EMA centralised 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 centralised procedure as MAA using a well-established use dossier; and
  • Identifying any other major deficiencies in the dossier that may prevent an MAA using the centralized procedure.
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