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Areas of activity

Life Sciences & Healthcare

The simplicity of competence at your service

“Well regarded team strongly recommended for regulatory matters and highlighted for its work in related IP issues.”
(Chambers Global 2020)

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The proven knowledge of the business and processes of pharmaceutical companies and the in-depth knowledge of the rules and regulations that govern their operations are the two characteristics that make our Life Sciences team a solid and reliable partner.

The sobriety and concreteness of our style allows us to be precise and prompt in our answers, giving companies opinions and advice tailored to their real needs.

We like working with and for the client. We believe in relationships based on transparency and loyalty where the use of technology supports the essential human contact.

Our core business is to take care of all pharmaceutical and biotech companies, providing each one with the most appropriate help to protect and sustain the success of their products.

For Big Pharma we act as experts on highly specialized and niche issues by integrating with the company's legal team.

For large, medium and small companies we act as the consultant at their side for the management of the legal aspects related to the relationship with EMA and AIFA, the authorizations and the negotiation of the price and redeemability and other regulatory aspects.

Along with the regulatory aspects related to products, our contribution extends to the entire product life cycle from clinical trials to marketing and support for the definition of the best market access strategy, also taking care of all communication issues from advertising to scientific information.

Thanks to our in-depth knowledge of the most complex pharmaceutical regulations we are able to provide our assistance in similar sectors such as cosmetics, medical apps, medical devices, food supplements and veterinary drugs.

Membership of Conférence Bleue, a prestigious European network that unites the most important law firms in the pharmaceutical, healthcare and medical fields, allows us to remain up-to-date and competitive in a rapidly changing sector, giving our clients the security of the best and most complete assistance.

In addition to legal counselling, we provide our assistance in a wide range of civil and administrative lawsuits in which we represent our clients in product liability cases, public tender appeals and pharmaceutical spending measures.

Together with our colleagues dealing with Intellectual Property Law we work to defend trademarks, patents and know-how.

We provide assistance in extraordinary M&A transactions related to the transfer of company branches or shareholdings. We are experts in the management of pharmaceutical compliance and privacy and data protection regulations.

Our team also offers assistance in arbitration proceedings before self-regulatory bodies such as the Institute of Advertising Self-Discipline (IAP) and the Jury of Farmindustria.

Life Sciences Sections

We assist clients in litigation and out-of-court cases concerning regulatory aspects of drugs Marketing Authorizations with reference to their:
  • issuance;
  • maintaining;
  • revision;
  • protection.

Furthermore, we offer assistance and consulting services on pricing systems, on classification for the reimbursement of drugs by the National Health Service.

We address our services to national and international companies requiring assistance in the following issues:

  • antitrust;
  • best practices and compliance (also in relation to national and international ethical codes, GMPs, GDPs and GCPs);
  • contracts drafting (licenses, MA transfers, manufacturing, toll manufacturing, distribution, storage, co-promotion and co-marketing);
  • joint ventures, company transfers and share transfers as well as all the extraordinary operations in the relevant field of industry;
  • participating in public tenders;
  • privacy;
  • advertising, competition and parallel imports issues;
  • relationships with regulatory authorities (AIFA – Italian Drug Administration, Ministry of Health);
  • clinical trials.

In this field we offer our clients our expertise developed with reference to manufacturing, commercializing (EC marks, regulatory activity, relationships with competent authorities), contracts drafting, advertising, participation in tenders for public authorities’ supplies.

This requires an experience and knowledge of regulatory and advertising legislation as well as experience in the field of relevant litigation.

The specific knowledge of life sciences allows our lawyers to handle also the issues pertaining to health-care law, possible new product liabilities or dangerous activity liabilities as well as to connections with the rules of the Consumers’ Code.

This means handling litigations before competent authorities.

In this field we offer our clients the consulting activities on topics connected to administrative liability of public authorities (Legislative Decree no. 231/2001) and we contribute to draft and revise the organization standards and we participate in vigilance bodies.
We provide assistance in relation to health data protection legislation with particular reference to:
  • clinical trials;
  • scientific information;
  • market surveys.

Sectors in which we operate:

The professionals

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