Next Generation Partners

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

EU regulatory: Pharma, medical devices and biotech in Belgium

Arnold & Porter

Arnold & Porter‘s life sciences team is bolstered by the arrival of Fabien Roy from Hogan Lovells International LLP who brings extensive expertise in navigating the complex EU regulatory frameworks within medical device and pharmaceutical regulatory matters.

Bird & Bird

Bird & Bird is called upon by market-leading corporations to advise on complex, business-critical regulatory and commercial matters. The team has recently supported clients in relation to key EU initiatives, including draft proposals under the EHDS, the Critical Medicines Act and the Pharma Package. The practice demonstrates strength in pharmaceutical and regulatory litigation. Practice head Marc Martens covers the full lifecycle of medicinal product and biomedical device development. Kevin Munungu brings deep expertise in EU regulatory and procurement matters, while Benedicte Mourisse advises on core life sciences regulatory issues.

Praxisleiter:

Marc Martens


Weitere Kernanwälte:

Kevin Munungu; Benedicte Mourisse


Kernmandanten

Polpharma Pharmaceutical Works, Neuraxpharm, Laboratorios Lesvi S.L.U.


Ethics Committees of several Belgian Universities: Université de Mons, Université de Namur, Catholic University of Louvain, UCLouvain.


Teva Pharma


Sumitomo Pharma, Marines Transparency Belgium, AdHoc Clinical, Envyzant, InhaTarget Therapeutics


IDRx, Articure, Boehringer Ingelheim, Gilead, Larima Therapeutics, CAMP4 Therapeutics, Analysis group


Azelis Group NV


Novo Holdings and Novo Nordisk


STADA Arzneimittel AG


Highlight-Mandate


  • Representing Polpharma in the high-profile regulatory dispute over generic access to Tecfidera.
  • Represented several pharmaceutical companies and Belgian universities in litigation brought by GAIA seeking access to confidential Ethics Committee documents.

Crowell & Moring

Boasting experience with mandates ranging from settlement and distribution agreements to parallel imports and emerging digital health issues, Crowell & Moring advises clients on the full spectrum of pharmaceutical regulatory issues. Practice head Kristof Roox combines IP litigation experience with regulatory expertise across the pharmaceuticals and medical sectors, while Jurgen Figys‘ biomedical background and deep knowledge of life sciences regulation strengthen the team’s offering.

Praxisleiter:

Kristof Roox


Weitere Kernanwälte:

Jurgen Figys; Christopher Dumont


Referenzen

‚We work with Crowell & Moring on a very regular basis, especially regarding public law and public procurement in the life sciences sector. The team, and in particular Kristof Roox, think very pragmatically and strategically, always with the aim of bringing products to market or keeping them on the market.‘

‘Very knowledgeable and professional.’

‘Understands the needs of the customer and the business deeply.’

Kernmandanten

Viatris


Zentiva


Sandoz


Honeywell


International Generic and Biosimilar Medicines Association (IGBA)


Medicines for Europe


Neuraxpharm


Polpharma


Aurobindo


PPTA (Protein Plasma Therapeutics Association)


PrOxi Biotech ApS


Stada Arzneimittel AG


Synthon


Highlight-Mandate


  • Advised Viatris in a dispute with Bayer over the drug Xarelto (Rivaroxaban).
  • Assisting multiple pharmaceutical companies with market generic DMF products in the European-wide DMF (Tecfidera) litigation.
  • Advising Viatris on a variety of regulatory questions.

HOYNG ROKH MONEGIER

IP and life sciences regulatory boutique, HOYNG ROKH MONEGIER, advises on the entire lifecycle of medicinal product and device development, combining high-level regulatory support with market-leading IP expertise. The team handles EU and national regulatory matters and is experienced in disputes heard before European and domestic courts. Practice head Liesbeth Weynants possesses extensive experience in patent litigation and regulatory matters. She is also recognised for her contributions to addressing unfair competition, privacy, and data protection issues within the life sciences sector.

Praxisleiter:

Liesbeth Weynants


Weitere Kernanwälte:

Tim Robrechts


Kernmandanten

Biontech


Teva


Biocodex


Pfizer


Regeneron


Vertex


Highlight-Mandate


Sidley Austin LLP

Sidley Austin LLP has strong relationships with EU institutions and regulators and is reputed for its depth of expertise in enforcement, competition, trade and data privacy mandates. Its esteemed clientbase consists of pharmaceutical, biotechnology, medical device and life science clients. Practice head Maurits Lugard brings deep insight from his prior experience at the European Commission. Maarten Meulenbelt focuses on EU regulatory, litigation and competition issues, while Michele Tagliaferri is highly experienced in compliance mandates. Josefine Sommers regularly assists clients with GMP/GCP and EMA procedures. He is adept at handling lifecycle strategy and promotional issues, offering particular expertise in cell and gene therapy matters.

Praxisleiter:

Maurits Lugard


Weitere Kernanwälte:

Maarten Meulenbelt; Michele Tagliaferri; Josefine Sommers


Referenzen

‘A very knowledgeable, pragmatic, professional, friendly team. It is a real pleasure to work with them, and you know that you are in good hands.‘

 

Kernmandanten

Les Laboratoires Servier


Highlight-Mandate


  • Acts as co-lead counsel for Les Laboratoires Servier in appeals before the CJEU relating to a General Court judgment that annulled key European Commission findings of infringement under Articles 101 and 102 TFEU. The case concerns significant competition law issues in the pharmaceutical sector.

Simmons & Simmons

Simmons & Simmons is known for its digital health, biopharmaceuticals and medical device sector expertise, acting for manufacturers, distributors and importers in both cross-border and domestic mandates. The team has a wealth of regulatory experience and regularly assists with legislative development efforts.  Co-heads Olivier Mignolet and Annabelle Bruyndonckx benefit from significant healthcare regulatory expertise and are active in clinical trial, compliance and promotion mandates.  Jérémie Doornaert advises on commercial and data protection matters for life science clients, while Nele Jonckers provides regulatory guidance and coordinates multinational compliance projects. Jérémie Doornaert advises on commercial and data protection matters for life science clients, while Nele Jonckers provides regulatory guidance and frequently coordinates multinational compliance projects.

Praxisleiter:

Olivier Mignolet; Annabelle Bruyndonckx


Weitere Kernanwälte:

Jérémie Doornaert; Michael Bulckaert; Nele Jonckers


Kernmandanten

Air Liquide


Align Technology Switzerland


Andocor


DG Pharma


Gilead


GlaxoSmithKline Pharmaceuticals


GlaxoSmithKline Biologicals


Medista


Noventure


Ipsen


Octapharma


Ontex


Robertet


Samsung Bioepis


Servier Benelux


Trasis


Zimmer GmBH


Highlight-Mandate


A&O Shearman

A&O Shearman’s life sciences team advises clients across the entire product development lifecycle, from approvals and pricing to marketing, data exclusivity and procurement. The team also has strong IP and patent litigation capabilities and benefits from an extensive multi-jurisdictional reach from the Belgium office. Practice head Tine Carmeliet guides pharmaceutical, medical device, and biotech clients through complex EU regulatory procedures.

Praxisleiter:

Tine Carmeliet


Kernmandanten

EQT Life Sciences


Highlight-Mandate


  • Advised EQT Life Sciences on a substantial minority investment in PanTera, one of the most promising Belgian growth companies that specialises in next-generation radio pharmaceuticals.

Hogan Lovells International LLP

Hogan Lovells International LLP team in Brussels is well placed to advise on EU, Belgian, French, and Portuguese law. The practice offers comprehensive support to pharmaceutical, medical device, and healthcare clients across regulatory, IP, product liability, and data protection matters. Cláudia Mendes Pinto advises on a wide range of regulatory and commercial issues. Practice head Fabien Roy left the firm in January 2026.

Weitere Kernanwälte:

Cláudia Mendes Pinto; Hélène Boland; Anastasia Vernikou


Referenzen

‘Dedicated associates who are both practical and professional. Very collaborative and helpful to our organisation.’

‘Hélène Boland has been standout to work with. She listens to what information we have and is focused on what we need as a result, or is able to provide us with guidance to obtain a better result than we had envisioned on our own.’

 

Kernmandanten

Adverum Biotechnologies


Celgene Corporation


AESGP


Highlight-Mandate


  • Advised Adverum, a clinical-stage gene therapy company focused on addressing unmet medical needs in ocular and rare diseases, on establishing a framework compliant with the Clinical Trials Regulation and the GDPR for their clinical trials and future activities worldwide.
  • Advises 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 (ATMPs).

Jones Day

Jones Day has a strong presence in the digital health sector, advising on telemedicine, digital products, AI, and big data solutions. The team, which boasts robust litigation capabilities and a pan-European reach, supports clients seeking to navigate new regulatory frameworks. Practice head Cristiana Spontoni advises pharmaceutical and medical device companies on legal, regulatory, and compliance matters. Jörg Hladjk and Philipp Werner are of note, bolstering the team further with extensive experience in the digital health sector.

Praxisleiter:

Cristiana Spontoni


Weitere Kernanwälte:

Jörg Hladjk; Philipp Werner


Kernmandanten

AbbVie Inc.


Accelmed Partners


Amolyt Pharma SAS


Ascensia Diabetes Care Holding AG


Biocom California


BioMarin Pharmaceutical Inc.


Cibus, Inc


GE Healthcare


Grand Duchy of Luxembourg


Institut Pasteur


MedTech Europe


Reneo Pharmaceuticals


Highlight-Mandate


  • Represented AbbVie in a landmark Dutch class action alleging excessive medicine pricing during the patent period, based on a human rights and duty of care theory. As the first case of its kind in the Netherlands, it required coordinated cross-border and cross-practice expertise, demonstrating the firm’s integrated global capabilities.
  • Represents BioMarin in a wide array of regulatory, legal and litigation matters. These include assisting with national pricing and reimbursement matters, the performance of clinical trials and post-market studies, sector-specific healthcare compliance and data privacy matters.
  • Successfully represented Biocom California in the landmark Illumina case (C-611/22) in which the European Court of Justice invalidated the European Commission’s unlawful new Article 22 policy asserting jurisdiction over transactions falling below EU and national notification thresholds.

Osborne Clarke

Osborne Clarke advises a range of life sciences clients, from scale-ups to multinational corporations, on various EU regulatory and quality matters. Their expertise extends to medical device, product and digital health mandates. The team assists with EU-wide quality systems, regulatory standards, market entry strategies and good manufacturing practices. Practice head Vladimir Murovec focuses exclusively on the healthcare sector and is recognised for his compliance expertise. Other notable names include Louis Hoffreumon and Fjoralba Spahiu.

Praxisleiter:

Vladimir Murovec


Weitere Kernanwälte:

Fjoralba Spahiu; Louis Hoffreumon


Referenzen

‘Osborne Clarke’s EU compliance team in Brussels is widely recognised in life sciences for the deep regulatory know-how and a practical, solutions-driven approach to issues. This is true across our full product portfolio (pharma, medtech, and food supplements).‘

‚They are champions at handling cross-border regulatory matters with technical skill and an understanding of the commercial realities facing us in the healthcare industry. They are regarded on the EU market for being responsive and thoughtful, and for working in a genuinely collaborative way.‘

‘Vladimir Murovec is our go-to person for all things regulatory or compliance. He stands out for being not just sharp on the law, but also down-to-earth and approachable — even with complex topics like new digital health rules or the quirks of EU device regulations. He really knows his stuff.‘

Kernmandanten

Alain Afflelou International


Amgen


ATB Therapeutics


Baxter (Vantive)


Bepharbel Manufacturing


BioSenic


Bluefin Biomedicine, Inc.


Chemviron


Circular Innovation Fund


CooperVision


Danone


Diageo


Equashield


Elaia Fund


ESAB Corporation


Grifols


Hu-Friedy


Humble Brands


Impossible Foods, Inc.


Just Eat Takeaway.com


Karl Storz


KiOmed Pharma


Medi-Market Group


Mission Foods UK Ltd.


Negio Therapeutics


neuroClues


Novo Nordisk


OncoDNA


Photocure


Puratos Group


Royal Canin


Samsara Vision, Inc.


Seegene, Inc.


Starbucks


Stellaris


Steris, Inc.


Sunrise


Synergia Medical


UCB


Vésale Bioscience (Inteliphage)


Vives Fund


Weight Watchers


Zambon


Highlight-Mandate


  • Advised Samsara Vision, Inc. on EU-wide regulatory issues for supply chain and cross-border registrations, and provided multi-jurisdictional guidance on national rules for KOL engagement, tenders, clinical investigations, and consulting arrangements across Europe.
  • Advised Grifols on the ethical and healthcare compliance considerations involved in cross-border interactions with healthcare professionals participating in congresses, site visits, and consulting activities at scientific events in Europe.
  • Advised Puratos Group on establishing a compliance framework for EU and International Nagoya Protocol regulations, developing decision tools and guidance to help their global R&D teams navigate complex cross-border requirements for accessing and using genetic resources.

ALTIUS

ALTIUS houses a life science team which boasts significant contentious, regulatory and transactional expertise. Its esteemed clientbase includes pharmaceutical, healthcare and biotech entities, who are active across several jurisdictions. Co-heads Christophe Ronse and Philippe de Jong bring deep IP and patent expertise, while Kirian Claeyé focuses on a wide array of regulatory issues related to clinical trials, market launch strategies and life cycle management.

Praxisleiter:

Christophe Ronse; Philippe de Jong; Kirian Claeyé


Weitere Kernanwälte:

Bregt Raus


Referenzen

‘The team are responsive, provides translations of the law into practical advice, and is collaborative.’

‘The team provides quick advice and has deep knowledge of the applicable regulations.‘

‘Kirian Claeyé is hands down the most knowledgeable lawyer in the Belgian life sciences industry.’

Kernmandanten

AbbVie


Anicura


Azelis


Bayer Cropscience


Bayer Pharma


Beiersdorf


Bolton Adhesives


Equine America


Euroseeds


Ferring


Gilead


Hipra


MARS


Merck Sharp & Dohme (MSD)


Midmark


Novartis


Organon


P3Lab


Highlight-Mandate


  • Advised Syngenta, a member of the Biocontrol Coalition, on the legal advantages of adopting a distinct legal act for biocontrol products.
  • Represents and advises Bayer regarding the enforcement of orphan drug market exclusivity.
  • Advises Merck Sharp & Dohme in relation to the implementation of various new EU Directives and upcoming EU pharma reforms.

Reed Smith

Reed Smith advises pharmaceuticals, biotech and digital health clients, assisting them with their regulatory obligations from the initial product development to marketing and enforcement. Practice head Wim Vandenberghe focuses on regulatory pathways, product classification and marketing authorisations, and also assists with regulatory due diligence and post-acquisition integration in the life sciences sector.

Praxisleiter:

Wim Vandenberghe


Referenzen

‘Wim Vandenberghe creates an atmosphere of deep thought guided by flexibility and creativity. He has taken our challenges and created a meaningful path forward.’

 

Highlight-Mandate


Stibbe

Stibbe assists clients with complex regulatory issues in the life sciences sector, drawing on close collaboration with its competition, IT and public law practice groups. The team combines expertise in compliance, litigation and product registration. Co-head Ignace Vernimme represents clients before regulators and courts in high-stakes matters, while Philippe Campolini brings strong IP and life sciences experience to serve the needs of Belgian and international clients.

Praxisleiter:

Ignace Vernimme; Philippe Campolini


Weitere Kernanwälte:

Louis Bidaine


Kernmandanten

Mylan


Lifescan


CSL Behring


Highlight-Mandate


  • Assisted 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 (containing the active substance “tobramycin”).
  • Advised PSG Equity on the acquisition of a stake in the Corilus group.
  • Providing complex regulatory advice to Lifescan, a diagnostic systems manufacturer with products focusing on the diabetes market, specifically blood glucose monitoring systems, on the marketing of medical devices for diabetic patients in Belgium.