What we do
A boutique law firm based in the Republic of Malta (EU), and New York (U.S.), AnthiaZammit Legal offers cutting-edge professional legal services to clients in highly regulated markets and industries worldwide.
Pharmaceutical & Healthcare Law
Handling of policy and regulatory matters before the European Commission, European agencies and….
Corporate & Commercial Law
AZ Legal offers comprehensive corporate and commercial law advice. It offers a full range of…
Food law aims at ensuring a high level of health protection. An integrated “farm to fork” approach is a general principle…
Occupational Health & Safety
We assist our clients in compliance with Occupational Health & Safety requirements…
Data Protection Law
In a digital age and an era of cloud computing, personal data is constantly collected and…
With significant experience in drug commercialization and the negotiation, drafting, review, and execution of transactional agreements, our firm understands the global challenges of healthcare delivery; drug pipeline development; intellectual property; data protection; merger and acquisition advisory; and multi-country market entry, market expansion, and marketing strategy.
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).