Next Generation Partners

Rising Stars

EU regulatory: Pharma, medical devices and biotech in Belgium

Bird & Bird

Counting many of the largest pharma and biotech companies worldwide as regular clients, Bird & Bird is equally comfortable handling cutting-edge work for innovators and generics alike. Marc Martens, who co-heads the firm's global life sciences and healthcare group, has specific expertise in biobanking, advanced therapies, clinical trials and data exclusivity disputes. More broadly, the practice has recently been particularly active in the digital health space, and has also assisted with a number of matters related to the Covid-19 pandemic. In team news, Nicolas Carbonnelle was promoted to partner in May 2022.

Practice head(s):

Marc Martens

Other key lawyers:

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


‘Very easy to work with, very capable.’

Key clients

Polpharma Pharmaceutical Works


Teva Pharma

Kaneka Eurogentec

PDC*Line Pharma SA

Terumo Europe

Op2Lysis SAS


Essencia (

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

European Commission: SMART-BEAR project

EG (formerly Eurogenerics)

Cooley LLP

Cooley LLP's 'deep knowledge of the industry and the regulations' ensures that key players from the life sciences industry trust the firm to handle issues arising throughout the entire lifecycle of their products. Recent highlights have included advising on regulatory issues concerning multijurisdictional clinical trials at all phases, advanced therapeutic medicinal products, and in vitro medical devices. Life sciences practice head Elisabethann Wright is a 'truly outstanding person to have alongside in the metaphorical trenches of regulatory disputes'. Associate Jessica Koffel regularly supports Wright on complex matters.

Practice head(s):

Elisabethann Wright

Other key lawyers:

Jessica Koffel


‘It’s the depth of specialised knowledge and experience of the individuals which makes the difference. You are dealing with people who have seen things before, even complex technical/medical matters.’

‘They give reassurance and instil confidence.’

‘Elizabethann Wright is a truly outstanding person to have alongside in the metaphorical trenches of regulatory disputes.’

Key clients


Sixth Street

Horizon Therapeutics


ZOLL Medical


Work highlights

  • Advised SCYNEXIS on its exclusive license agreement with GSK for Brexafemme.
  • Advised Horizon Therapeutics on its agreement to be acquired by Amgen.


IP and life sciences boutique HOYNG ROKH MONEGIER stands out as a go-to advisor for the biggest global names in the pharma and biotech spheres. The firm expertly deals with regulatory issues at both the European and national levels; exclusivities, market authorisation and access, pharmacovigilance, transparency, pricing, reimbursement and compliance issues all form part of the team's regular workload. The group is equally well regarded for its contentious expertise, and is frequently instructed to handle internal and external investigations, as well as representing clients in product qualification and registration cases. Liesbeth Weynants is the key senior contact.

Practice head(s):

Liesbeth Weynants

Other key lawyers:

Tim Robrechts

Key clients






A&O Shearman

The primary area of expertise for A&O Shearman's life sciences team lies at the intersection between regulatory and patent work for pharma clients. The group also handles the full gamut of product approval, pricing, marketing and advertising, data exclusivity, public procurement, and reporting issues. Senior associate Tine Carmeliet solely oversees the department following the retirement of senior counsel and previous co-head Geert Glas in December 2023.

Practice head(s):

Tine Carmeliet

Covington & Burling LLP

Covington & Burling LLP's client base comprises major domestic and multinational pharma companies, as well as a wide array of biotech, diagnostic, medical device, cosmetic and food companies, ranging from start-up ventures to industry leaders. Key areas of strength include advising on issues related to Covid-19, incentives for innovation, reimbursement procedures, the new Medical Devices and IVD Regulations, and global pathogen-sharing rules. Peter Bogaert and Bart Van Vooren oversee the life sciences department; the latter has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol.

Practice head(s):

Peter Bogaert; Bart Van Vooren

Other key lawyers:

Rosa Oyarzabal

Key clients



BioNTech SE

Bristol-Myers Squibb


Eli Lilly

The European Confederation of Pharmaceutical Entrepreneurs

Johnson & Johnson Group

MedTech Europe

Royal Canin

Aloe Vera of Europe


International Federation of Pharmaceutical Manufacturers and Associations

Takeda Pharmaceutical Company

Work highlights

  • Representing Aloe Vera of Europe in litigation before the EU General Court, including a request for suspension, against a Commission Regulation banning HAD for an infringement of the precautionary principle.

Crowell & Moring

As a result of its recognised IP and litigation expertise, Crowell & Moring is particularly valued by key players from the generics industry. The firm's areas of strength range from advising on marketing authorisations, pricing and reimbursement issues, government reforms, and off-label use questions to representing industry associations in investigations. Recently, there has been markedly increased activity in the digital health space. Co-managing partner Kristof Roox works closely with senior counsel Jurgen Figys on complex mandates.

Practice head(s):

Kristof Roox

Other key lawyers:

Jurgen Figys; Wietse Vanpoucke; Eline Van Bogget


‘They have huge knowledge of regulatory matters related to pharmaceuticals. They investigate matters in great detail. They adapt to the client needs and create added value in terms of innovative ideas and thinking out of the box.’

‘Kristof Roox is a top partner.’

Key clients


Viatris (formerly Mylan)




Medicines for Europe


Fresenius Medical Care



Hogan Lovells International LLP

Noted for its ‘outstanding experience and collaborative and practical approach‘, the multidisciplinary life sciences and healthcare group at Hogan Lovells International LLP is well placed to handle IP, product liability, regulatory, transactional and data protection issues. Fabien Roy ‘stands out across the region for his expertise and reliable advice‘; he oversees the Brussels-based offering, regularly collaborating with his counterparts across Europe to offer clients cross-border assistance. Cláudia Mendes Pinto is another key team member.

Practice head(s):

Fabien Roy

Other key lawyers:

Cláudia Mendes Pinto; Hélène Boland


‘This practice is extremely collaborative and efficient in gathering information and providing helpful and practical advice for us. Their portal helps us keep our information together and we can collaborate well using this method.’

‘Fabien Roy and Hélène Boland provide great value for our company. Hélène is resourceful and works with colleagues in a cost effective manner. They provide a holistic approach to our business and consider our goals and objectives. They are an extension of our business and not just a service provider.’

‘What made the difference for us is that Hogan Lovells has always ensured they get a deep understanding of our relevant products and associated business processes, which allows them to provide very specialised and to the point advice, with a very business-orientated mindset. They have also taken on a coordinating role when we require advice touching upon different markets.’

‘Fabien Roy provides very specialised and business-orientated advice. We especially appreciate that he puts himself in the shoes of in-house counsel to anticipate our needs.’

‘HL International has a great asset of experts in different fields that makes their advice usually very useful. They show a genuine interest in getting to know your company, products and the problems you are facing, so that they are able to offer the best service possible. They possess a very good knowledge of the intricacies of the current regulatory landscape in the EU and guide you through those very effectively.’

‘Fabien Roy is always available for a chat; he gets knowledgeable about your difficulties and follows up closely on his commitments. He is very interested in getting up to speed with current developments on the new regulations framework and I have even coincided with him in seminars and congresses he is attending either as a participant or as a speaker.’

‘The team is particularly strong in pharma regulatory and biotech. They have outstanding experience and collaborative and practical approach. The lawyers are very skilled, knowledgeable, extremely efficient and absolutely pleasant to work with. There isn’t a topic that they would not be able to handle and keep the top standard.’

‘Fabien Roy stands out across the region for his expertise and reliable advice. His interest in life sciences and a good sense for practical solutions makes it a pleasure to work with him! Open-minded, enthusiastic and responsive. His team is great too!’

Key clients

Adverum Biotechnologies


Bracco Imaging

Celgene Corporation

Colospan Ltd.

Dexcom, Inc.

Establishment Labs


Synapse Biomedical, Inc.

Work highlights

  • Assisting clinical-stage gene therapy company Adverum Biotechnologies with setting up a GDPR compliant framework for its upcoming clinical trials in the EU and UK.
  • Assisting Celgene on an ongoing basis with supply chain, manufacturing and clinical trials regulatory aspects throughout Europe concerning its authorised and investigational Advanced Therapy Medicinal Products.
  • Providing Dexcom with ongoing global regulatory assistance concerning its continuous glucose monitoring (CGM) systems.

Jones Day

Jones Day's prodigious client base spans major pharma companies, leading research institutes, key medical technology and device manufacturers, and investors. Cristiana Spontoni, who acts as co-head of the firm's healthcare and life sciences practice, handles work ranging from the pre-market phase, including clinical trials, to post-market issues, including product liability, marketing, distribution, and compliance. Mandates in the digital health space have been keeping the group particularly busy in recent times.

Practice head(s):

Cristiana Spontoni

Other key lawyers:

Preslava Dilkova

Key clients

Arsenal Capital

Astellas Pharma Inc.

BioMarin Pharmaceutical Inc.

Cellectis SA

Institut Pasteur

International PNH Interest Group

Lipton Teas and Infusions

MedTech Europe

Pharmaceutical Product Development


Sumitomo Dainippon Pharma

Work highlights

  • Advising BioMarin, a major developer of innovative biopharmaceuticals for rare diseases driven by genetic causes, on a wide array of regulatory issues.
  • Advising Sumitomo Dainippon Pharma on a wide variety of ongoing regulatory matters on a pan-European and global basis.
  • Advising Institut Pasteur on an array of EU-wide and global regulatory matters.

Sidley Austin LLP

Sidley Austin LLP is particularly well regarded for its contentious expertise, with clients noting that the firm is 'used to challenging the authorities and has a great network throughout the EU to assist with local regulators' contacts'. The team's 'excellent knowledge of the industry' also ensures seamless provision of advice on issues affecting producers and developers of medicinal products and medical devices throughout their life cycle. Maurits JF Lugard heads up the life sciences practice.

Practice head(s):

Maurits JF Lugard

Other key lawyers:

Maarten Meulenbelt; Josefine Sommer


‘Excellent knowledge of the industry; good insights into upcoming legislative developments, client-oriented solutions.’

‘Great client care and attention to client needs; good value for money; outstanding quality of work.’

‘Their EU regulatory team has a deep knowledge of the med tech regulatory framework. What makes them special, though, is their ability to adapt to clients’ needs. We see them more as trustworthy business partners rather than as an external legal advisor.’

‘Josefine Sommer is a fantastic practitioner. She is extremely competent, but also available at short notice. She provides regulatory but also strategic advice. She, and her team, provide realistic timelines for project completion.’

‘The team is highly knowledgeable and has a lot of experience with EU regulatory authorities, it is used to challenging the authorities and has a great network throughout the EU to assist with local regulators’ contacts. The team is also very business-minded and pragmatic.’

‘The team is very competent, knowledgeable in their field, quick to respond and pick up on the matters, they usually accommodate easily the client’s schedule. They are solution driven, pragmatic and very business oriented.’

Key clients

Servier Laboratories Limited

Doctipharma SAS

Work highlights

  • Representing Les Laboratoires Servier before the Court of Justice of the European Union in appeals against a General Court judgment.
  • Representing Doctipharma, a subsidiary of DocMorris, in a reference for preliminary ruling procedure before the CJEU.

Simmons & Simmons

The healthcare and life sciences team at Simmons & Simmons is differentiated by its niche expertise in blood-based medicines, in vitro diagnostic medical devices, biopharmaceutical products, and advanced therapy products. Olivier Mignolet oversees the firm's Brussels office, and regularly leads on complex regulatory mandates along with Annabelle Bruyndonckx; between them, the duo cover the gamut of matters, from research and development, to production, to marketing authorisation.

Practice head(s):

Olivier Mignolet; Annabelle Bruyndonckx

Key clients

Align Technology Switzerland GmbH

AlloVir, Inc.

Andocor NV

Coloplast NV

GlaxoSmithKline, Inc. (Global Health)

Samsung Bioepis Co., Ltd.

The Oncidium Foundation

Stallergenes Greer, Inc.

Vitaflo France SARL


The ‘very practical‘ team at ALTIUS counts innovative companies in the pharma industry, as well as hospitals, private equity investors, and leading groups from the dental and veterinary spheres among its key clients. Christophe Ronse brings his IP expertise to bear on relevant life sciences work, while Philippe de Jong has extensive regulatory experience.

Practice head(s):

Christophe Ronse; Philippe de Jong

Other key lawyers:

Kirian Claeyé


‘Extremely deep knowledge of the subject and really ready to share the key points so that in-house and external legal teams can optimise quality service.’

‘Clear, no-nonsense, quick advice provided in a friendly and accessible way.’

‘Very practical, translating the law to clear advice.’

‘Fast and correct advice.’

Key clients





Applied Medical



Merck (MSD)

Work highlights

  • Assisted the The European Mirocals Consortium (Horizon 2020 EU Project) with the negotiation of a worldwide exclusive license agreement (including clinical trial results) with ILTOO Pharma.
  • Advised Hipra on the implementation of new EU Regulation 2019/6.
  • Advised Merck Sharp & Dohme on the impact of anti-tampering devices under the Falsified Medicines Directive on the parallel import of medicines.

Osborne Clarke

The appointment of counsel Vladimir Murovec as practice head at Osborne Clarke has ensured that the life sciences regulatory department has ‘become a top choice among life sciences businesses as they navigate EU market entry or face compliance hurdles'. The team utilises a threefold sector approach which focuses on biotech and pharma, digital health, and healthcare. Clients range from global businesses to fast-growth start-ups and market challengers.

Practice head(s):

Vladimir Murovec


‘Vladimir Murovec is a professional lawyer with in-house counsel experience. This is helpful in getting practical solutions.’

‘Highly knowledgeable team. Easy to approach and quick replies.’

‘The life sciences regulatory team is well embedded in the Brussels office’s global service offering. This means that they can easily collaborate with other practices to deliver not only EU regulatory advice but also raise red flags or provide advice on data topics, IP protection or confidentiality issues, contract law and commercial aspects, etc in any cross-border health tech projects.’

‘Vladimir Murovec has unique experience in advising health tech and pharma businesses on the regulatory framework in which they operate and is a go-to EU lawyer for global life sciences businesses launching in Europe or experiencing challenges with regulators or notified bodies.’

‘Vladimir Murovec has a quick understanding of new health technologies and products with a digital element. He provides sound, risk-based advice that is useful and actionable. I have recommended him to my peers in the industry due to the quality of his work.

‘The team is good at apprehending the issues and providing solutions in a timely manner.’

‘Vladimir Murovec brings a special blend of expertise to the table when it comes to guiding pharma companies through the EU regulatory maze. He’s become a top choice among life sciences businesses as they navigate EU market entry or face compliance hurdles. He is well connected and provides seamless cross-border advice to global players in the pharmaceutical industry.’

‘The Osborne Clarke EU life sciences regulatory team is right at home in the heart of the Brussels office, making them a go-to team for a range of legal services. What makes them stand out in that space is that they’re not just a tech or life sciences firm – they’re both.’

Key clients

Afflelou Group

Alnylam Pharmaceuticals

BePharBel Manufacturing

Bone Therapeutics


Epstein, Becker & Green


Novo Nordisk



Work highlights

  • Advising a global private equity fund on EU and domestic healthcare and medical device regulatory due diligence and potential acquisition of an international medical device business across ten European jurisdictions.
  • Advising an international pharmaceutical business on the launch of a cross-border communication campaign around pipeline initiatives and disease awareness activities in compliance with EU pharmaceutical regulations.
  • Advising a consumer health and cosmetics giant on the qualification of a beauty care technology as a product without an intended medical purpose under European medical devices regulations.

Reed Smith

At Reed Smith, Wim Vandenberghe heads up the dedicated EU life sciences regulatory sub-practice. The team provides 'timely and confident advice' on obtaining the necessary approvals or clearances, managing supply chains, preparing for inspections and audits, marketing the product, and responding to enforcement actions. Assisting with compliance procedures is another strength.

Practice head(s):

Wim Vandenberghe


‘Strengths: medtech expertise, timely and confident advice.’

‘Wim Vandenberghe: responsive, very client focused, and a nice person!’

‘The team was able to tap into the Reed Smith Global Solutions offering to support us in a standardised way on our compliance programme. The work is supervised by a senior lawyer, which gives us confidence of the quality.’


The IP and life sciences team at Stibbe works closely with the firm's public law department to advise on regulatory issues affecting pharma companies and other key players in the healthcare sector. Recent highlights have ranged from representing clients in disputes with the Belgian pricing authorities, to assisting with the development of clinical trials. Ignace Vernimme and Philippe Campolini are the key senior names to note.

Practice head(s):

Ignace Vernimme; Philippe Campolini

Other key lawyers:

Louis Bidaine

Work highlights

  • Representing a major global producer of generic and biosimilar pharmaceutical products in proceedings before the CJEU against the European Commission in relation to an exemption granted to one of its competitors on the market exclusivity of its product.
  • Advising a global developer of medicines on a government tender for the processing of Belgian blood in medicines.
  • Advising a global developer of medicines on a new pricing model for advanced therapy medicinal products whereby the payments for the products are spread out over several years.