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Health Care & Life Sciences

Carnelutti represents health care, pharma and medical devices entities of all sizes and levels of complexity, which gives us a 360-degree perspective on the challenges and opportunities presented by the evolving health care and life sciences system.
Carnelutti acts both for companies, and their investors across the industry, including in the pharmaceuticals, biotech, veterinary, medtech, diagnostics and healthcare sectors. We advise biotechs, medical device and pharmaceutical companies, research institutions, laboratories and health care institutions developing a diverse range of device and drug technologies.
The practice operates on a cross-border basis and covers the full spectrum of legal support.
Our cross-departmental team of attorneys serves as advisors to health care providers, managed care entities, insurers, group health plans and vendors. This experience allows us to combine our know-how and insight into cutting-edge best practices and strategies pursued by industry participants with our in-depth understanding of each client’s local circumstances and actual operations.
We frequently combine our knowledge of the health care regulatory landscape with our strong corporate, tax, labour and employment, employee benefits, intellectual property, real estate and litigation experience to align our services with our health care clients’ legal needs.
Carnelutti has experience working across a broad range of small-molecule and biologic pharmaceuticals, devices and technologies, both as counsel to life sciences companies and to former company executives. Carnelutti adds value to businesses at every stage of the company life cycle—formation, financing, IP protection, clinical trials, approval, product sales and marketing, and patent term extension.
The uniqueness of Carnelutti’s offer is the assurance of having direct and exclusive every day access to legal support at the highest levels of seniority with 30 years of industry experience and with a personal, continuous and trustworthy relationship with the perfect synthesis between the best of competences, practical know-how and immediate responsiveness a flexible and dynamic advisory model with time-smart operational decisions.
Carnelutti is an experienced and authoritative guide to the commercial essentials needed by companies to help them navigate the complex Italian and international rules, preventing disputes from arising and resolving them when they do.
Carnelutti gives full time advice: a team of skilled professionals available every day to its clients, whose close collaboration delivers a dynamic synergy from its different specializations.

Contracts and Third Parties

Legal advice on the needs of the company and the relationship with sales representatives and distributors.

  • Contracts - preparation, amendments and termination of contracts;
  • Management of contract exits and variations of the “area”, “product” and “commissions”;
  • Due Diligence and Audit for the identification of commercial partners;
  • Legal aspects of the relationship between the commercial networks and the public administration;
  • Labour law;
  • Judicial and extrajudicial assistance in cases of litigation regarding relations between the company and its commercial network;
  • Extraordinary operations concerning commercial network organization: M&A, spin off, turn around, corporate restructuring.

Product Liability

  • Extrajudicial and judicial assistance in cases of litigation.

Compliance

Ethical aspects, civil and criminal liability in the relationship between companies and public administrations. Specific skills regarding cross examination of the single phase of a purchasing process by the public administration VS criminal law breach risk(s).

  • D.Lgs. 231/2001;
  • Ethical Codes;
  • Advice on promotional activities;
  • Market access;
  • Advice on relationship rules with public employees;
  • RWE Real World Evidence;
  • Clinical trials;
  • Assistance on relations with reference bodies such as AIFA (Italian Pharmaceutic Agency) , EMA (European Medicines Agency) , FDA (Food & Drug Administration);
  • Relations between public administrations and private companies;
  • Support to Italian trade associations.

Administrative Law

Assistance in handling public tenders.

  • Management of all process steps for participation in public tenders;
    • Identification of needs and determination-quantification;
    • Assistance on the drawing up of the offer on the basis of the contract notice;
    • Definition and drafting of contracts.
  • Judicial and extrajudicial assistance in litigation cases.

Regulatory

Legal aspects of compliance with the technical rules laid down by national legislation and the European Community on the subject of research, testing, production and commercialization of pharmaceutical products and medical devices.

  • Assistance and legal advice on regulatory aspects of specific themes;
    • Recall plans;
    • AIC – Authorization for marketing of new drugs;
    • CE mark;
    • Marketing.
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