Pharma due diligence
Alacrita’s due diligence work involves working with clients to understand the reason for the due diligence as well as particular areas of focus, the depth of assessment and the timelines. Given the breadth and depth of our consulting expertise, we undertake all aspects of due diligence, including science/technology, intellectual property, preclinical and clinical development, regulatory, manufacturing, commercial and medical due diligence. Our clients include pharma companies, biotech companies and financial investors.
Our due diligence activities will often include:
- an initial review of the data to gain an understanding of the materials available and the expertise required
- acting as a local scouting office, to broaden our client’s geographic reach
- selecting a team of technical evaluators who are matched to the client’s need; we sometimes supplement our consultants’ expertise with primary or secondary research
- reporting our findings in a risk assessment dashboard, enabling our client to see quickly where any key risks lie
- providing an opinion as to whether the company or asset faces lower or higher than average risk, compared to industry averages.
We also perform reality checks, which are often useful before entering into formal due diligence and can reveal areas that present greatest risk. This could then be the focus of more detailed analysis.
Case study: regulatory due diligence
A clinical stage biopharmaceutical specialist needed support with its regulatory due diligence activities.
We assembled an expert team comprising an ex-MHRA 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
Alacrita has a multiple examples of case studies of due diligence in the pharmaceutical industry available here.
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