Next Generation Partners

Rising Stars

Firms To Watch: EU regulatory: Pharma, medical devices and biotech

Osborne Clarke recruited managing associate Vladimir Murovec from Simmons & Simmons as head of its life sciences regulatory team in October 2022, adding significant regulatory and compliance expertise in the medical device and digital health sectors, as well as traditional pharma and life sciences.

EU regulatory: Pharma, medical devices and biotech in Belgium

Bird & Bird

Bird & Bird leverages its global intellectual property strength to act for major global names in pharma, life sciences, and biotech, handling patent protection and enforcement alongside the full range of regulatory issues, including R&D, product development and licensing, and authorisations, as well as advising on cross-border transactions. Marc Martens heads up the team, and has a notable specialism in the biotech and advanced therapies spaces, advising on the development of innovative products, while Jean-Christophe Troussel  takes the lead on contentious IP and Paul Hermant provides broad tech and data regulatory support. Nicolas Carbonnelle was promoted to partner in May 2022 and is a specialist in life sciences regulatory issues, including standout expertise in biobanking and the use of biological materials in medical products.

Practice head(s):

Marc Martens

Other key lawyers:

Paul Hermant; Nicolas Carbonnelle; Domien Op de Beeck; Jean-Christophe Troussel

Key clients


Terumo Europe

Precision Medicine Group

Polpharma, Hexal (Sandoz), Almirall

Teva Pharmaceuticals




PDC*Line Pharma SA

Floridienne S.A.

Recipharm AB

Op2Lysis SAS


Eargo Inc



FHP BV, Creafund NV, Hyloris Pharmaceutical S.A, Purna Pharmaceuticals


Essencia (

Novadip, MaSTherCell SA (Catalent), EMBL, Vital Strategies, UCB

European Commission: SMART-BEAR project

Work highlights

  • Assisted Floridienne S.A. in the acquisition of Biotrac NV (i.e. an indirect acquisition of shares in Florinvest NV) and the related sale of two portfolio companies of its Life Sciences division engaged in the production of vanilla (i.e. SOPRAL (Madagascar) and KAMAPIM (Papua New Guinea)).
  • Advised Rayner on its investment in HASA OPTIX Belgium.
  • Working with 26 organisations in a European Commission funded (€20 million) project that draws on big data to improve the health and wellbeing of European citizens.

Cooley LLP

Led by specialist life sciences regulatory practitioner Elisabethann Wright, the team at Cooley LLP offers broad cross-border capabilities across clinical trials, product approvals for medical products and devices, and regulatory investigations by European and global authorities, alongside representing a global client base in litigation before regulators and European courts. Clients include major European and global names in the pharma, life sciences, and biotech spaces, including long-standing players and new market entrants.  The firm is also able to draw upon privacy and tech regulatory expertise, allowing it to handle complex, business-critical issues relating to patient data.

Practice head(s):

Elisabethann Wright

Other key lawyers:

Alexander Wenzel; Jessica Koffel


‘The team has strong expertise and is a trusted partner for EU regulatory issues in pharma.’

‘I’ve worked with Elisabethann for years, and trust her judgement and ability to understand and weigh the business needs against the regulatory landscape.’

‘Elisabethann’s team in Brussels operates on a pan-European base that is unique in European firms as most firms stay localized in a specific country. This allows for practice and guidance that can be broadly applicable (where appropriate) and saves on multi-firm communications.’


Boutique intellectual property and life sciences firm HOYNG ROKH MONEGIER advises across the lifecycle of medical products and devices, handling domestic and EU-level regulatory issues relating to market access, product authorisation, exclusivity issues and pricing, combining compliance advice with a strong capability in litigation before European courts. The firm is also able to draw upon patent prosecution and protection expertise, and is particularly noted for its work in the pharma and biotech spaces. Experienced specialist Liesbeth Weynants heads up the team, which also includes counsel Tim Robrechts, who contributes trade secrets and patent litigation expertise. Delphine Borgniet left the firm in July 2022.

Practice head(s):

Liesbeth Weynants

Other key lawyers:

Tim Robrechts


‘Liesbeth is great and is very experienced at advising on the relationships between IP and regulatory matters.’

Key clients

Advanced Accelerator Applications (AAA)



Ceva Santé Animalé




Teva, Teva Belgium, Yeda Research


Covington & Burling LLP

Covington & Burling LLP has EU-level and domestic regulatory expertise in key European jurisdictions, advising pharma and life sciences companies on product development and distribution issues, as well as issues relating to R&D and product labelling and litigation before regulatory authorities and European courts. The team is also active on behalf of trade associations on responses to upcoming legislation and pandemic preparedness. Peter Bogaert, who is highly experienced in regulatory compliance advice as well as litigation, leads the team alongside Bart Van Vooren, who advises life sciences and food clients on innovative products and regulatory challenges.

Practice head(s):

Peter Bogaert; Bart Van Vooren


‘Unique in depth knowledge of the regulatory frameworks of a variety of product types, allowing for expertise to be leveraged from one sector to the other.’

‘Peter Bogaert has unmatched analytical skills which combined with his regulatory legal knowledge can be a game changer to solve complex issues.’

Key clients



BioNTech SE

Bristol-Myers Squibb (BMS)

GlaxoSmithKline (GSK)

Eli Lilly

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

Johnson & Johnson Group

MedTech Europe

Royal Canin

Aloe Vera of Europe


International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

Takeda Pharmaceutical Company

Work highlights

  • Representing Sanofi in multiple proceedings before the EU General Court regarding complex regulatory questions around the use and protection of clinical trial data, and “New Active Substance” status.

Crowell & Moring

Crowell & Moring advises a global range of pharma and life sciences clients on the regulatory aspects of product development throughout the product lifecycle, non-contentious IP issues such as licensing applications and collaboration agreements, as well as handling cross-border tech and data regulatory issues for an array of key sector players. The team is led by Kristof Roox, who has deep expertise in the pharma and biotech sector, encompassing regulatory and intellectual property issues, while senior counsel Jurgen Figys is a go-to for product development work.

Practice head(s):

Kristof Roox

Other key lawyers:

Jurgen Figys

Key clients





Fresenius Medical Care


Medicines for Europe




Viatris (formerly Mylan)



Vondts Advocaten

Work highlights

  • Advising Precirix on the ownership of patent applications under Belgian law.
  • Assisted a major pharmaceutical company with a variety of regulatory issues such as data exclusivity, patent linkage, skinny labelling and the regulatory aspects of parallel imports, and helped them with the design and implementation of an export and sanctions compliance programme.
  • Advised a leading international pharmaceuticals company in two disputes regarding a rival company’s promotional materials.

Hogan Lovells International LLP

Hogan Lovells International LLP advises a global client base, including major European and global pharma players, on regulatory issues relating to medical devices and pharma products, handling regulatory approvals, intellectual property, and data issues, as well as litigation against European authorities in issues such as product liability and consumer protection. Fabien Roy  leads the team, specialising in EU and national medical devices regulatory issues, with standout expertise in clinical trials and MPR compliance for complex medical devices such as in vitro products.

Practice head(s):

Fabien Roy

Other key lawyers:

Helene Boland


‘The team works well together and enjoys the challenges of finding options for our business that are compliant and make sense. They strive to “see around the corner” to help us consider our moves today and how they can seamlessly transition to future needs with less work. They are practical and detailed and know the industry and requirements very well. They are able to provide local advice quickly when needed and get others up to speed as they know us well and understand our goals and needs in a fast paced environment. The team is also very pleasant, and it is very welcome to have conversations that provide options and solutions and also are engaging on the personal side.’

‘Fabien Roy and Helene Boland provide very clear advice and practical options for businesses to consider. They work well together and have a good relationship, which translates into our company being able to utilize either person for the work. Ms. Boland provides exceptional work product on the agreed upon timeline with budget taken into account. Her availability is unparalleled, and she greets each new challenge with care and enthusiasm. Their subject matter expertise for life sciences is superb and has facilitated our company’s objectives in a time sensitive and cost effective manner. It is comforting knowing that they are as invested in our company’s outcomes as we are — their time and attention to detail and communication stands out.’

‘The Hogan team in Brussels has very good understanding of our company’s products and associated complexities. They have a very client oriented approach, whereby they proactively reflect on the type of information and assessment we need to proceed with our business and associated transactions.’

‘We especially appreciate working with Fabien Roy because of his client oriented mindset and his easy way of communication and providing legal advice. He listens very actively to understand our needs and ensures very close and rapid follow up. He has very deep understanding of our complex products and provides to the point and relevant advice.’

Key clients

Adverum Biotechnologies

Celgene Corporation

Colospan Ltd.

V-Wave Ltd.

Canon Medical Informatics Inc.

Dexcom, Inc.

Becton, Dickinson and Company

Adverum Biotechnologies

Celgene Corporation

Colospan Ltd.

V-Wave Ltd.

Canon Medical Informatics Inc.

Dexcom, Inc.

Becton, Dickinson and Company

Work highlights

  • Advising Adverum on setting up a GDPR-compliant framework for their upcoming clinical trials in the EU and UK and advising on related clinical activities.
  • Advising Celgene Corporation on supply chain and manufacturing issues connected with Advanced Therapy Medicinal Products (ATMPs).
  • Advising Colospan on regulatory aspects regarding the conduct of post-market clinical investigations in Germany, Italy and Switzerland.

Jones Day

Jones Day offers full-service regulatory support to life sciences and healthcare clients, including global pharma companies, research institutions, and a growing number of businesses in the cosmetics industry. The team offers standout expertise in M&A, intellectual property issues, product development and launch, and data protection issues, and is able to handle complex cross-border arrangements in collaboration with its global offices. The team is led by Cristiana Spontoni, a specialist in the pharma, medical devices, and cosmetic space, who handles cross-border transactional, regulatory, and privacy issues.

Practice head(s):

Cristiana Spontoni

Other key lawyers:

Preslava Dilkova


‘The team is quite personable and a pleasure to work with. Not only do they have great in depth knowledge in their particular focus areas, they have offices around the globe, where they are able to consult with others who are specialized in other areas of the law and geographies to provide comprehensive coverage for all of your needs.’

‘Preslava Dilkova is a pleasure to work with and will work diligently to ensure your company’s interests are met, keeping in mind your needs when new opportunities may present themselves.’

Key clients

AbbVie Inc.

Arsenal Capital

BioMarin Pharmaceutical Inc.

Institut Pasteur

Pharmaceutical Product Development (PPD)


Sumitomo Dainippon Pharma

Work highlights

  • Representing BioMarin in a wide array of regulatory, legal, and litigation matters.
  • Advised CellCarta on the acquisition of Biogazelle NV, a Belgian company and leader in genomic testing solutions.
  • Advised Misonix, Inc. (NASDAQ: MSON) in its USD 518 million acquisition by Bioventus Inc. (NASDAQ: BVS).

Sidley Austin LLP

Sidley Austin LLP‘s expertise encompasses regulatory compliance, including license applications and post-Brexit business operational issues, alongside intellectual property work and a standout capability in European litigation for life sciences clients, including regulatory challenges relating to market access, and clinical trial free riding proceedings. The firm has an international client base including major life sciences and cosmetics producers. Maurits JF Lugard leads the team, and is an expert in European and global regulatory issues and associated litigation, having represented major clients before the European Commission, European courts, and international regulatory bodies.

Practice head(s):

Maurits JF Lugard

Other key lawyers:

Maarten Meulenbelt


‘Sidley’s team is outstanding not only in terms of knowledge of EU (e.g. clinical trials, marketing authorizations, orphan designation) and national (e.g. pricing and reimbursement) regulatory matters, but also for their ability to deliver clear, pragmatic and fast advice on very complex affairs.’

‘Maarten Meulenbelt is a great litigator, definitively the best partner to work with on high-profile matters.’

‘The team around Maarten Meulenbelt has a longstanding experience in the pharma sector, is multinational and therefore a top address in this sector for Brussels work with the European Commission.’

‘I have been working many years with Maarten Meulenbelt and he is an excellent lawyer with a very deep and detailed knowledge of EU and Dutch pharma law.’

Key clients


Versailles BV

Laboratoires Théa


AB InBev

Work highlights

  • Representing Vemedia, an affiliate of Versailles BV, in proceedings regarding the refusal of the Dutch Medicines Evaluation Board to grant a marketing authorisation for melatonin as a medicinal product.
  • Representing Laboratoires Théa for a series of cases challenging the marketing authorisation of a generic medicinal product “free riding” on the client’s clinical trials.

Simmons & Simmons

Advising an international array of pharma and life sciences companies, alongside medical devices producers, Simmons & Simmons advises on regulatory issues relating to digital health technologies, medicines, biopharma products, and cosmetics, alongside other products, handling sector-specific considerations such as product approvals and trials alongside tech and data regulatory concerns. The team, which is noted for its cross-border expertise, is led by Olivier Mignolet, who regularly litigates before European courts on behalf of pharma and medical devices companies in cases relating to product liability and market access, alongside life sciences regulatory expert Annabelle Bruyndonckx, who has played a key role in vaccine approval matters, alongside public procurement issues.

Practice head(s):

Olivier Mignolet; Annabelle Bruyndonckx

Key clients

Align Technology Inc.

beMedTech asbl/vzw

Sanofi Belux SA/NV

GlaxoSmithKline PLC (US)

Allen & Overy LLP

Allen & Overy LLP advises life sciences companies on regulatory compliance issues, as well as working with research organisations and industry associations on research projects and responses to regulatory and legislative developments, including litigation. Senior counsel Geert Glas, whose clients include a number of multinational pharma giants, leads the team alongside senior associate Tine Carmeliet, with both offering broad regulatory expertise, including on industry-specific issues and data privacy, to life sciences and pharma clients.

Practice head(s):

Geert Glas; Tine Carmeliet

Work highlights

  • Advised a university on a dynamic data registration system to gather data from female patients and healthcare professionals with respect to the use of pharmaceuticals during pregnancy and lactation using high-quality observational research and real-world data.

Reed Smith

Reed Smith advises global pharma and life sciences clients on broad regulatory compliance issues relating to product development, European market entry, and marketing, also working continuously with major industry names on commercial data and operational issues. The team is led by specialist life sciences practitioner Wim Vandenberghe, who works with medical devices, cosmetics, and pharma companies throughout the life cycle of products.

Practice head(s):

Wim Vandenberghe


Stibbe provides dedicated public law and intellectual property expertise to life sciences and pharma clients, which include medical device and product producers, hospitals, and research universities, advising clients on Belgian and European regulatory compliance alongside providing representation in disputes with pharma regulatory bodies and intellectual property authorities, as well as European courts. Experienced intellectual property and life sciences litigator Ignace Vernimme leads the practice alongside Philippe Campolini, who is primarily focused on compliance advice.

Other key lawyers:

Louis Bidaine


‘Availability, multidisciplinarity and effective teamwork.’

‘Philippe Campolini and Louis Bidaine are able to synthesize complex facts in such a way as to make them understandable for a judge who would have to deal with a case and to identify and highlight the essential and striking elements that will serve their argument. They also take care to explore all possible strategies without rushing headlong in order to select the actions that will have the best chance of yielding positive results.’

Work highlights

  • Representing Mylan, a global leader in generic and biosimilar pharmaceutical products, in proceedings before the Court of justice of the EU against the European Commission in relation to an exemption granted to one of its competitors on the market exclusivity of its product Tobi Podhaler as an orphan medicinal product.
  • Advising CSL Behring Herziening wet on a government tender for the processing of Belgian blood in medicines whereby one pharmaceutical company is granted the exclusivity of this market.
  • Advising CSL Behring on a new pricing model for advanced therapy medicinal products (ATMPs) whereby the payments for the products are spread out over several years to lighten the financial burden of the social security systems.