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Pharma mergers and acquisitions have been on the rise in recent years, particularly as large pharmaceutical companies look for new sources of revenue to replace blockbuster drugs in view of the shift toward more specialized and precision treatments. In 2019, the pharmaceutical industry saw a record-breaking 1,276 merger and acquisition deals totaling $411 billion.1 Even despite the pandemic, deals continued to close in 2020.
Mergers and acquisitions in pharma offer mutual benefits for large companies and small biotechs. The big companies rapidly expand their research and development pipelines. The emerging biotech companies gain a profitable exit strategy or the opportunity for greater brand recognition. However, with large deals come a complex Regulatory Asset Transfer process or Market Authorization Transfer (MAT) process, in which business and regulatory compliance continuity are critical considerations. During MATs, regulatory teams must weigh several operational aspects while creating a roadmap that takes them into account. Here are some key questions for regulatory teams that are necessary for planning and executing a successful MAT process.
This can be a massive, time consuming and often overlooked step in the project plan of a MAT process. Moreover, for mature assets, companies have thousands of documents, many of which may be in paper format which might need to be scanned and transferred. Subsequently, documentation transfer requirements for all formats and operational aspects should be discussed at the pre-deal stage.
Having regulatory professionals at the table to ask the right questions during mergers and acquisitions can prevent an array of risks, avoid delays and ensure a successful MAT process. Bringing regulators expertise into the fold early on can help companies initiate mutually beneficial, seamless deals without unwarranted and costly challenges.
Cecile Riboud is Senior Director of Integrated Global Compliance, IQVIA.