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Pharmaceuticals and Healthcare regulatory

Harnessing regulatory strategy to deliver innovation

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The sector specialists across our network help some of the world’s foremost pharmaceuticals and healthcare companies achieve their strategic goals at critical points in the life-cycle of their most important products, and in their transactions and disputes.

The sector specialists across our network help clients achieve their strategic goals and manage risk in their transactions and disputes, and at critical points in the life-cycle of their most important products.

Our cross-border team also handles major product recall and crisis management, and follow on disputes and investigations, regulatory challenges, procurement disputes, class actions and insurance coverage.

 

 

 



Accolades

'‘The team is highly recommended for their IP and regulatory skills, combining advice and litigation capabilities.‘
Life Sciences & Healthcare, Legal 500 Italy

'A top-tier team, very impressive.'
Pharmaceuticals & Biotechnology, Legal 500 UK

'The lawyers combine the high quality and sophisticated knowledge of a boutique law firm with the approach, mind-set and language skills of an international firm. So what we get is a combination of high-quality legal advice given to us in a very concise, practical and helpful way'
Legal 500, Life Sciences & Healthcare, Italy

'Tier 1, Pharmaceuticals & Biotechnology'
Legal 500 UK

'Band 1, Life Sciences'
Chambers Australia

'Tier 3, Life Sciences & Healthcare'
Legal 500 Italy

'Firm of the Year: Patent Strategy & Management'
LMG European Life Sciences Awards 2020

'Firm to Watch: Litigation & Enforcement'
LMG European Life Sciences Awards 2020

'Life Sciences Firm of the Year – Italy'
LMG European Life Sciences Awards 2020

Learn more about how we help our clients in

Pharmaceuticals and Healthcare

View Sector

Recent Experience

a major global biotech

on regulatory issues related to requirements for, and the interplay between, different paediatric rewards applicable to one of its key orphan drugs

MiRNA Green

in relation to the launch and correct classification of new products based on a disruptive technology for extracting microRNA from plants, including advising on strategy to mitigate risks related to a misclassification under the contiguous categories of medicinal products, novel food and food supplements

a major global biotech

on pricing and reimbursement issues for some of its key productions, including the application of reimbursement linkage provisions and hospital tender requirements

FederFARMACO

a company representing pharmaceutical wholesalers on regulatory affairs and intellectual property matters

A pharmaceuticals company

specialising in rare diseases on regulatory issues related to the off-label use of medicinal products and right to access to dossiers submitted to the EMA for medicinal product approval

a pharmaceuticals manufacturer

on national and international standards on interactions with healthcare professionals and healthcare organisations, transparency and disclosure obligations at industry level and under the law

Our People

Diverse Knowledge, in-depth experience