MICHELLE GANDOLFO advises clients throughout their product life cycle, from clinical development programs to marketing authorization pathways and post-market compliance issues. Michelle assists clients on a wide variety of regulatory and compliance issues relating to medicinal products, medical devices, biotechnology, food, and cosmetics.
Michelle also supports clients conducting internal investigations, in developing, auditing, and enhancing compliance programs, and advising clients in matters related to anti-bribery legislations, whistleblowing, and ESG issues. She regularly advises on EU sustainability matters, including on compliance with the Corporate Sustainability Reporting Directive (CSRD) and the proposed Corporate Sustainability Due Diligence Directive (CS3D).
Michelle also conducts compliance reviews and regulatory due diligence in connection with mergers and acquisitions, joint ventures, and third-party engagements.
Prior to joining Sidley, Michelle worked at international and boutique law firms in Milan (Italy), assisting life science companies on regulatory and compliance matters, and representing clients on commercial, product liability, and patent litigations.