EU regulatory: Pharma, medical devices and biotech in Belgium

Bird & Bird

At Bird & Bird, the team's recent work included advising biopharmaceutical company UCB on compliance with local and international regulations relating to biobanking activities. Other drivers of work included clinical trials matters, public procurement and advice on medical devices issues. Practice head Marc Martens and counsel Nicolas Carbonnelle are the names to note.

Practice head(s):

Marc Martens

Other key lawyers:

Nicolas Carbonnelle

Key clients

Zentiva

Cipla

Essenscia

bio.be

Janssen Pharmaceutica

Johnson & Johnson

Louvain University

Work highlights

  • Provides ongoing advice to sector organisation bio.be on EU regulatory matters pertaining to accessing human biological samples for manufacturing advanced therapy medicinal products.

Hogan Lovells International LLP

Hogan Lovells International LLP's life sciences practice has a notable strength in advising medical devices and pharmaceutical companies on the whole life cycle of medical products, which often involves cross-border elements. Practice head Elisabethann Wright, who has extensive expertise in life sciences regulatory work, has recently been advising companies on digital health issues. Fabien Roy is a name to note.

Practice head(s):

Elisabethann Wright

Other key lawyers:

Fabien Roy

Work highlights

  • Assisted a multinational technology company with regulatory assessments of thermal technology.
  • Assisted a US-based manufacturer of orphan medicinal products with clinical trials.

HOYNG ROKH MONEGIER

Liesbeth Weynants heads up the practice at HOYNG ROKH MONEGIER. The firm is well known for its traditional strength in IP and it is also adept at advising prominent medical devices and pharmaceutical companies on a broad range of life sciences regulatory issues.

Practice head(s):

Liesbeth Weynants

Key clients

Biocodex

Boehringer Ingelheim

Daiichi Sankyo

Orion Corporation

Teva

Crowell & Moring

Kristof Roox leads the team at Crowell & Moring, which provides ongoing advice to Novartis on a number of parallel import cases. Regulatory matters and contentious patent-related mandates remain key areas of activity for the group. Senior counsel Gunther Meyer has extensive experience in the pharmaceutical, medical devices and biotech fields.

Practice head(s):

Kristof Roox

Other key lawyers:

Gunther Meyer

Testimonials

This practice always shows itself to be very professional with the necessary expertise and perseverance. The legal knowledge regarding procedures concerning medical devices is excellent. Working with them is the guarantee of professionalism‘.

Gunther Meyer’s professionalism is outstanding. The knowledge he has about medical devices gives us confidence that the things we let him follow up are going perfectly. The communication also goes very well‘.

Key clients

Mylan

Sandoz

Novartis

Synthon

Pharma Patent

Jones Day

Jones Day's team has 'a plethora of expertise in EU regulation and law', and leverages its cross-practice strengths (particularly in the antitrust and M&A arenas) to advise prominent pharmaceutical and medical devices companies on a broad spectrum of life sciences matters. Practice head Cristiana Spontoni is 'an excellent life sciences lawyer with in-depth knowledge in the regulatory pharmaceutical, medical devices and care provision field'.

Practice head(s):

Cristiana Spontoni

Testimonials

The lawyers and associates at the office really understand the EU regulatory process and have excellent project management skills that deliver results‘.

Cristiana Spontoni is very reliable and one of the best in her field‘.

Key clients

BioMarin

BioPontis

Plasma Protein Therapeutics Association (PPTA)

Santen Pharmaceutical

Work highlights

  • Provides ongoing advice to the PPTA on a range of regulatory matters, including opposing national measures that are incompatible with EU law for labelling plasma products and the potential revision of the EU regulatory framework pertaining to blood and plasma products.

Simmons & Simmons

Simmons & Simmons’ team is experienced in handling medical devices and digital health mandates (that often have a cross-border dimension) for global pharmaceutical companies and biotech and medical devices entities. Olivier Mignolet and counsel Annabelle Bruyndonckx are key contacts. Also recommended is associate Vladimir Murovec, who is very experienced in advising healthcare and life sciences companies on digital health issues.

Practice head(s):

Olivier Mignolet; Annabelle Bruyndonckx

Other key lawyers:

Vladimir Murovec