Challenge:
A clinical stage biotech needed support with its regulatory due diligence activities for products in the respiratory field.
Solution:
Alacrita 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 the following activities:
- reviewing proposed validation plans for a new manufacturing process and assessing suitability for MAA using a centralized procedure
- reviewing the packaging 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
Explore Our Due Diligence Services
Alacrita's due diligence consultants have been a trusted source of pharma and biotech DD for over 15 years, underpinned by our ability to ensure each due diligence exercise is supported by individuals with the precise industry expertise required to be thorough, complete and accurate.