The Firm
AnthiaZammit Legal is a niche law firm focused on offering strategic advice and professional services in some of the most highly regulated markets and industries worldwide.
We provide a tailor-made approach and rapid response to new challenges and evolving opportunities in a highly competitive business environment.
The unique nature of our clients’ products, including: medicinal products; medical devices; cosmetics; food products and infant formula; and specialty chemicals, are handled with strong appreciation of reputational risk, balanced by a robust commercial approach.
Anthia A. Zammit LL.B, LL.D has advised multinational mega-cap and start-up companies and institutions operating in healthcare; life sciences; biotechnology; chemical; food, and pharmaceutical industries. She represents a diverse client-base encompassing Swiss; French; German; UK; Belgian; Dutch; Israeli; Maltese, and U.S. patients’ organizations, business associations, and companies, and also consults on cases of multi-location international law firms.
Anthia served as legal counsel to the Healthcare Business Section of the Malta Chamber of Commerce, Enterprise, and Industry, and as a member of the European Patients’ Forum (EPF) Policy Advisory Committee. EPF is a not-for-profit non-governmental-organization that represents the interests of an estimated 150 million patients in public health and health advocacy across Europe.
She worked at the Office of the CEO of Malta’s national competent authority, the Medicines Authority (the “Malta FDA”). The Medicines Authority is established by the Medicines Act (Chapter 458 of the Laws of Malta, transposing European Directive 2001/83) to protect and enhance public health through the regulation of medicinal products and pharmaceutical activities. Anthia also worked as Associate at a leading business and tax law firm in Malta.
Anthia’s profile was enhanced by her role representing private and publicly-listed companies during their global expansion in established and emerging markets; business development; contract negotiation; medicinal product launches; drug and vaccine licensing (centralized, decentralized and mutual recognition procedures); regulatory affairs; regulatory compliance; good manufacturing practice (EU-GMP); good distribution practice (EU-GDP); pharmacovigilance; data privacy; pricing & reimbursement; and marketing.
She is passionate about preventive healthcare, and interested in legislation as a means of increasing global access to safe medicinal products and vaccines. She is regularly invited as keynote speaker at high-level global conferences on invitation of the European Commission to discuss healthcare delivery; medical practice; digital health; e-health; mobile-health technologies and systems; personalized medicine; youth health; global business development in life sciences; international harmonization of regulatory requirements of pharmaceuticals for human use, and other topics.
Anthia received an LL.B (Bachelor of Laws) and an LL.D (Doctor of Laws) from the University of Malta. Her doctoral thesis Pharmaceutical Law in the EU and USA: The Impact on Public Health and the Pharmaceutical Industry, earned her the European Commission (DG Health and DG Research) and World Health Organisation Regional Office for Europe’s Young Gastein Scholarship.
Anthia is admitted to the practice of law in Malta (EU) and is a legal consultant in the State of New York (US).
Anthia Zammit
Anthia graduated from the University of Malta (Europe) with a Bachelor of Laws (LL.B) and Doctor of Laws (LL.D).
Associations
American Foreign Law Association; New York City Bar Association, Malta Chamber of Advocates
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The Firm
We counsel world-class companies, trade organizations, and patients’ associations in healthcare; life sciences; biotechnology; diagnostics and therapeutics; nanotechnology; food; chemical; medical device, and pharmaceutical industries. We also advise many of the world’s most renowned mega-cap and start-up companies, hospitals, clinics, and pharmacies.
With deep grounding in European Union and United States regulatory law, business and commercial law, and data privacy, we are dedicated to supporting our clients as they innovate, develop, and market breakthrough drug therapies, medical procedures, medicinal products, and vaccines for human use – enhancing high-quality healthcare access to patients on every continent.
We take great pride in achieving client satisfaction and repeat engagements owing to an intensive attention to detail and our mastery of complex intra- and inter- regional regulatory frameworks. Among the assignments executed are matters ranging from: i) regulatory affairs and global regulatory compliance ii) intellectual property (patents, trademarks, data privacy, and data security) iii) clinical trials iv) due diligence and good corporate governance v) licensing of manufacturing, production, and patient care facilities, and product registration vi) packaging and labeling vii) distribution, transport, and logistics viii) post-licensing marketing, advertising, and, ix) pricing and reimbursement in established and emerging markets.
We have assisted in establishing timelines and deliverables for product launches of innovative, generic, biologic, and biosimilar, prescription and over-the-counter medicinal products in the largest global markets; production requirements for GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), and GLP (Good Laboratory Practice) accreditation; evaluation and selection of geographic, physical, and online distribution channels; location of batch-release sites, pharmacovigilance requirements, and the roles of the Qualified Person (QP) and the Responsible Person (RP) under importer, manufacturer, and wholesale dealer licenses. We have also advised on the successful creation of interactive digital platforms; marketing tactics; product placement, and promotion via traditional and online media.
We have created tailor-made solutions for leading healthcare, pharmaceutical, life sciences, and biotech companies, hospitals, and medical professional groups establishing a global network of healthcare facilities; research and development (R&D); manufacturing and production; logistics, and transportation of active pharmaceutical ingredients (APIs), biologics, biosimilars, drugs, and vaccines for human use. We regularly interface with regulatory government agencies and national competent authorities, such as, the European Medicines Agency (EMA); the U.S. Food and Drug Administration (FDA); the International Conference on Harmonis/zation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), and the Malta Medicines Authority as a Reference Member State (RMS) in Mutual Recognition Procedures (Directive 2001/83/EC).
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