Nicola Landolfi

He/himSenior Lawyer
Rome
About

Nicola Landolfi is a Senior Lawyer in the Intellectual Property & Technology department and is based in the Milan office.

Nicola is a lawyer in the Intellectual Property & Technology department and is based in the Rome office.

He assists international companies in dealing with regulatory and compliance issues concerning medicinal products, medical devices, food supplements and other health-related regulated products.

Nicola’s area of expertise covers both EU and Italian law.

Areas of FocusIntellectual PropertyLife Sciences
Professional QualificationsAvvocato admitted to the Rome Bar

EXPERIENCE

  • Advised a pharmaceutical company on the regulatory procedure for obtaining a centralized marketing authorization for a vaccine against the COVID-19 in the EU.
  • Advised several companies on the transitional provisions governing the placing on the market of medical devices under Regulation (EU) 2017/745 (MDR).
  • Advised a US biotech company on compliance with the EU Tissue & Cell directive and its national implementation in Italy and other European jurisdictions.  
  • Assisted a Swiss company in assessing the possible classification of a well-being app as a medical device under Regulation (EU) 2017/745 (MDR).
  • Advised an Italian leading pharmaceutical company on the regulatory classification of a product as a medicine vs. food supplement in the context of criminal proceedings.
  • Assisted a US company on the implementation of certain home care clinical trial-related services in more than fifty (50) jurisdictions worldwide.  
  • Advised a UK company on the applicable rules to disseminate non-promotional and promotional materials on medical devices to the general public in France, Germany, Ireland, Italy, the Netherlands, Spain and the UK.
  • Assisted a Japanese pharmaceutical company in defending its data exclusivity and market protection rights pertaining to a triple combination medicinal product from two potential competitors preparing to enter the market with generic versions of the product.
  • Assisted a US biotech company running clinical trials in Italy and the EU on the review of all research and clinical trial agreements.
 
Languages
  • Italian
  • English
  • Spanish
Education
  • Roma Tre University of Rome, Law degree, 2014
  • University of Buenos Aires, Thesis abroad, 2014
  • University of Cordoba, Erasmus program, 2013

Prior Experience

  • Jul 2023 - to date, DLA Piper, Rome – Senior Lawyer
  • Oct 2019 - Jun 2023, DLA Piper, Rome – Lawyer
  • Dec 2018 - Sep 2019, global law firm, Rome – Associate
  • Jun 2017 - Nov 2018, global law firm, Rome – Junior Associate
  • Apr 2016 - May 2017, Dalla Vedova Studio Legale, Rome – Junior Associate

My latest insights

Publication

Life Sciences News in Italy: November 2024

9 December 2024 .12 minute read

Publication

DLA Piper Genomics Series: Navigating Regulatory Challenges in the Era of Cell and Gene...

24 October 2024 .21 minute read

News

DLA Piper advises MidEuropa on FAMAR acquisition

24 July 2024 .2 minute read

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Phone

+39 06 68 880 1
(Work, Rome)