At KG we guide our clients in the life sciences & healthcare industry through the legal, compliance and regulatory aspects that affect their business, both strategically as well as in their day-to-day operations. Our experience extends to all legal issues related to pharmaceutical products, medical devices and sanitary material, vaccines, biotechnology, pharmaceutical cannabis products, cosmetics, veterinary products, medical nutrition, food for special medical purpose, biocides and chemical reagents.

Main Areas of focus include, inter alia:

• Assistance in strategic transactions – manufacturing, distribution/co-distribution, storage, joint venture, branding, outsourcing, research, clinical trial, collaboration, co-promotion and other types of commercial agreements;
• Negotiation of contracts;
• Distribution channels and market access methods – redesigning of local distribution networks;
• Pricing and reimbursement policies – reimbursement strategies for new services, products and technologies, discounts schemes and other reimbursement solutions for patients;
• Discounting and rebating schemes – Clawback and Rebate;
• Tax considerations and implications of contemplated strategies and projects;
• Sales and marketing practices, including product launches and shortages proceedings;
• General regulatory matters – interactions with healthcare practitioners; educational and research grants; scientific events and similar activities; free products; samples; gifts and other business courtesies etc;
• Advertising and promotion practices and compliance with professional/industry ethics – Social Media content review;
• Labeling and packaging practices;
• Clinical trial implementation and other research and development activities;
• Market Researches;
• Pharmaceutical cannabis regulation;
• Assistance in implementation of patient programs;
• Digital health – experience on issues involving the new methods of health information delivery; internet platforms and mobile apps;
• E-Commerce and Internet Policies;
• Privacy and Data Protection;
• Intellectual Property;
• Competition – Pharmaceutical Antitrust – Dawn raid awareness and preparedness training courses;
• Parallel Import/Export activities;
• Compliance Programs – development and implementation of standard operation and anti-corruption policies;
• Corporate compliance programs – development and implementation of corporate compliance programs and audits;
• Public tenders and awards – preparation and processing of files and documents for public tender procedures, representation in court proceedings – attending negotiation procedures with public authorities regards supplied of NHS hospitals;
• Regulatory agency processes/public policy issues;
• Product Liability – strategic handling and assessment, including litigation;

We represent national and international companies in disputes covering the full range of industry operations, including:

• Contract disputes;
• Termination of distribution agreements;
• Collections from hospitals;
• Infringement of intellectual property rights;
• Product liability cases;
• Imposition of administrative fines by local authorities;
• Imposition of clawback and rebates;
• Recourses against State decisions.