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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

Recent Experience

a biotechnology company

 in relation to the launch of a new Food for Special Medical Purposes, including the requirements to be classified as such as well as labelling and advertising requirements

a global medical device company

on the feasibility of a new "direct-to-consumer" supply scheme in light of specific local rules (both legal and deontological rules) applying to orthodontists/dentists in Italy

a number of European pharmaceuticals companies

in relation to the multi-national product recall of a blood pressure treatment, following the discovery of potential carcinogens, and on related recovery issues 

a major US-headquartered biotech

in a product liability litigation before a Shenyang court in relation to the medicine provided to a patient in a clinical trial procedure

a global pharmaceuticals company

in relation to price and reimbursement procedures in Spain and access to information legislation

a global pharmaceuticals company

in on European Marketing Authorisation procedures, co-marketing and co-promotion agreements and commercialisation options in the context of the termination of a co-promotion agreement

Insights and updates

14th April 2020
The global Covid-19 pandemic has, to an extent, re-directed some of the actions and focus...
25th June 2020
On 11 June, the Court of Justice of the European Union (" CJEU ") ruled...
12th May 2020
Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical...

Diverse Knowledge, in-depth experience

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Pharmaceuticals and Healthcare

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