Significance of due diligence of MA / Dossier before acquisition

As it becomes more expensive and cumbersome to develop new medicines, the traditional approach of pharmaceutical and biotechnology companies to do everything from R&D through to commercialization is changing. Recent trends show that in-licensing and acquisition of products is fast becoming a favored way to offset the risk of investment in R&D and shortening the time to market the product.

The first step of any acquisition is to perform due diligence to identify and mitigate issues that could cause a bottle neck either during the product registration with health authorities (in case of a dossier acquisition) or during the commercial launch of the product in case of MA acquisition.

ProductLife Group can help pharmaceutical companies, distributors or start-ups with the technical due diligence of submission dossiers or marketing authorizations during the initial evaluation phase of licensing discussions, and subsequently support with the life cycle maintenance of those acquisitions. The technical due diligence of the regulatory and CMC sections of the product is performed keeping in mind the end results of the acquisition and considering factors including, but not limited to:

• Product type
• Target markets
• Age of data
• Number of changes made over a period of time (including changes anticipated in future)
• Process consistency
• Any commitments made in the past as part of regulatory approval
• Feasibility assessment for material, process or site transfer changes (technology transfer) to new manufacturing sites.

This provides a clear understanding of what is being inherited from the product acquisition and how much effort would be required to meet the necessary regulatory compliance. The results of this due-diligence facilitates defining responsibilties of each party and commercial valuation of the asset.

Contact us to find out more about how we can support you with your future product acquisition.