Anna-Shari Melin

ANNA-SHARI MELIN serves as the firm’s primary adviser on German life sciences regulatory law, with deep experience advising on EU regulatory requirements and their interaction with German implementation and enforcement. She acts as a trusted EU regulatory strategist for multinational companies navigating complex, cross-border regulatory matters.

Anna’s practice encompasses regulatory, compliance, and risk considerations across the full product life cycle for pharmaceutical, biotechnology, medical device, animal health, cosmetics, food and nutrition, and other consumer goods companies.

As the EU lead of Sidley’s pvlegal benchmarking forum, Anna has built substantial experience in pharmacovigilance (PV), including in animal health. She has a particular understanding of the operational and strategic needs of pharmaceutical, medical device, and food companies — including food supplement and food for special medical purposes (FSMP ) businesses — having been semi-seconded to global clients across these sectors and continuing to act as a trusted adviser to them.

Anna’s experience also spans GMP and broader GxP compliance, clinical trials, early access programs, and complex classification and borderline assessments. She supports local and global companies in anticipating and managing product life cycle and enforcement risk, including in relation to supply chain resilience and shortage prevention, product recalls, marketing and promotion, interactions with healthcare professionals, and related investigations and enforcement matters. Anna also supports life sciences transactions through regulatory due diligence and targeted advisory input.

Anna works closely with Sidley’s international life sciences regulatory team in Brussels, where she worked from 2016 until 2022, as well as in Geneva, London, Asia, and across the United States. Through regular multijurisdictional projects, Anna has built a well-established global regulatory network, supporting clients around the world across more than 60 jurisdictions through coordinated, multicountry regulatory intelligence and coherent cross-border risk analysis, delivered through her as a single, consistent point of contact.

Anna has represented clients before the European Commission, the European Medicines Agency, the European Court of Justice, and the German Federal Court of Justice (Bundesgerichtshof). She is fully qualified in Germany, having completed both German State Examinations, which include formal judicial training, and regularly develops litigation and pre-litigation regulatory arguments in matters involving EU and German enforcement risk, precedent, or broader policy implications.

Anna is also actively involved in life sciences ESG thought leadership and the firm’s Emerging Enterprises pro bono initiatives.

Prior to joining Sidley, Anna worked at other international law firms in Brussels.

• Advising Crown Bioscience in its acquisition of the IndivuServ business unit of Indivumed GmbH.
• Advising Gilde Healthcare in its acquisition of SDS Group.
• Advising RTI Surgical Inc. in its contemplated acquisition of a provider of spinal implant solutions that serve to address the unmet clinical needs of spine surgeons and their patients.
• Advising client on contemplated acquisition of leading specialty generics company.
• Advising a premier designer, developer, and manufacturer of medical devices focused on preventing infections and supporting patients and caregivers across the acute care markets on its asset purchase of a medical restraints manufacturer active on the EU, and in particular the German market.
• Advising a U.S.-based multinational medical devices and healthcare company under EU and German law with respect to various aspects of their business, including the disposal of medical devices under relevant electronic waste and infectious disease laws; pricing and advertising strategies prior to obtaining CE marking; and licensing requirements applicable to a broker company manufacturing pet food from medicinal product scraps.
• Counseling one of the largest Japanese pharmaceutical companies under EU and German law relevant to early access programs, including on agreements with German university hospitals covering the provision of a monoclonal antibody in the context of an individual treatment attempt.
• Advising a Germany-based multinational company in the context of an FCPA/anti-corruption risk assessment of operations in various EU countries.
• Advising an EU multinational food-products corporation on EU and German law relevant to the labeling, manufacture, and reimbursement of infant formula and follow-on products.
• Counseling a global alternative asset manager on in its due diligence process while acquiring a company focused on medicines for the central nervous system.

• Munich Bar Association (Rechtsanwaltskammer München).

Anna is involved in the firm’s Emerging Enterprises Pro Bono Program, which provides free legal support to eligible small- and medium-sized for-profit enterprises and market-focused non-governmental organizations and non-profits that have a clear social impact in developing countries across Africa, Asia, Central and South America, and the Caribbean. Anna has advised organizations such as the Wildlife Justice Commission and She Trades at the International Trade Centre (ITC).