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Transaction and Securities Disclosure Support and Due Diligence
You purchase rights, assets, and companies to build your business. The lawyers at Hogan Lovells advise global life sciences companies on the most sophisticated transactions.
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When purchasing a pharmaceutical or biotechnology product or business, or when you obtain financing for a purchase for product development activities, you need to ensure that your regulatory issues due diligence is handled properly.
In working with our clients, we frequently serve as special FDA counsel to companies, issuers, and underwriters in conjunction with initial public offerings and follow-on offerings. We perform due diligence valuations and due diligence reviews of regulatory issues, including the relevant product pathway for the product through the FDA, the EMEA/EMA, or other regulatory bodies. We also provide input on the regulatory issues presented in disclosures, including risk factors associated with offerings.
Additionally, we help draft descriptions of the FDA regulatory process for drugs, including biologics and animal drugs/veterinary medicinal products, and carry out similar analyses on regulatory processes in other countries, particularly those in the EU.
In our role as regulatory counsel, we work in conjunction with our colleagues in the Corporate and Securities practice to provide opinion letters on the regulatory sections of a prospectus.
Our capabilities at a glance
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Judicial review wins
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Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Representative experience
Routinely conduct due diligence of FDA and foreign regulatory law for a wide variety of corporate clients involved in Initial Public Offerings (IPOs) and other types of financings to corporate acquisitions.
Frequently help draft and revise the regulatory sections of security disclosure documents for many of our public company clients.
Conducted U.S. due diligence on FDA, intellectual property, and antitrust issues for a major pharmaceutical client's billion dollar, multinational acquisition of a major pharmaceutical product.
Provided U.S. and EU regulatory due diligence for numerous clients, including investment firms considering investments or loans to non-client companies with novel products.
A product considered for acquisition by an animal health industry client was at high risk of never being approved or having a major delay due to the sponsor needing to conduct in-depth environmental assessments.
Evaluated a proposed purchase of a veterinary medicinal product from the standpoint of EU and United Kingdom regulatory law.
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