M&A activities are increasing. Are you prepared?
Posted on the 7th September 2023
Pharmaceutical industry mergers and acquisitions (M&A) are complex, demanding, and highly resource-intensive endeavors.
Their success relies on timely execution to deliver shareholder value and meet critical regulatory authority commitments.
Regardless of their size, mergers and acquisitions always entail legal, financial, and regulatory implications, as well as quality and safety considerations. Failure to deliver is never an option.
Following the pandemic, global M&A activity plummeted to its lowest point in over a decade, with deal volumes and valuations taking significant hits. PwC's 2020 data showed a 48 per cent drop in volume and a 28 per cent decline in valuations in just a year.
However, the tide does appear to be turning and, as we approach the final quarter of 2023, the marked resurgence in M&A activity that has characterized this year shows no signs of abating.
Driven by cash-rich larger firms seeking to fill medium-term pipeline gaps and the adjustment of biotech valuations to more realistic levels, the markets are returning to pre-pandemic levels. This has led to substantial transactions as companies aim to expand market share, optimize their product portfolios, and venture into new domains.
At G&L Healthcare Advisors, we anticipate that M&A activities will continue to gain momentum in the foreseeable future, and we stand ready to guide our clients through the process with confidence.
M&A processes, by their very nature, can be lengthy and rigorous, with planning stages spanning up to six months and the actual contract execution often requiring a further 18 months.
Every M&A/integration/spin-off is different and requires a bespoke strategy.
G&L Healthcare Advisors’ unrivaled regulatory affairs function is uniquely positioned to advise clients and guide them on the critical path to success through the development and delivery of solutions tailored to their specific needs and goals.
Covering both operational and strategic perspectives, our extensive experience spans all aspects of regulatory and quality and includes key functions such as regulatory due diligence (pre-deal), marketing authorization transfers, core dossier builds for new market rollouts, CMC conformance, product rationalization, and labeling changes.
Sizeable M&A initiatives entail high volumes of critical regulatory activities and commitments which need to be performed in addition to “business as usual” regulatory activities.
This often requires additional regulatory headcount on a global basis, to successfully deliver critical integration activities or to cover resultant shortfalls of expertise within regulatory teams.
At G&L Healthcare Advisors, we understand the vital role regulatory plays in driving a successful M&A integration process, and we have a wealth of experience in supporting such initiatives in a flexible, scalable manner.
Our proficiency in understanding and addressing the myriad intricacies associated with M&A integration is pivotal in ensuring sustained market access and revenue generation for clients of all sizes, stages of development, or global locations.
To learn how our experts can support your Merger and Acquisition integration activities, please contact us here.
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