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.