The Life Sciences | Biotechnology | Product Registration | Product Liability Practice at KKG Legal focuses on providing comprehensive legal services to companies operating in the biotechnology, pharmaceutical, medical devices, cosmetic and food sectors.
Thanks to our interdisciplinary approach and collaboration with experts in various legal fields, we offer support at every stage of business, from product research and registration, through regulatory compliance, to bringing innovations to the market. We also provide comprehensive advice on product liability, including in areas such as product marketing, compliance with product safety regulations and manufacturers' liability for product defects.
Due to the complexity of the tasks posed by this specialty, not only knowledge and experience are required, but also a flexible and open approach, which characterizes our team. The range of competencies we have at our disposal also allows us to meet requirements not directly related to this particular specialty, but necessary in meeting the demands of our Clients.
In order to meet the specific needs of our Clients, we form project teams of experts from various areas, including the Practice of Compliance | Risk Management | Data Protection | AML, the Intellectual Property Practice, and the M&A | Transactions Practice.
WHAT WE HELP WITH
- Clinical trials: Legal support in the organization and conduct of clinical trials, preparation of contracts, assessment of regulatory compliance and representation in trial error proceedings.
- Product registration: Support in the process of registration of medicinal products, medical devices, cosmetics and dietary supplements, including support in registration obligations, post-registration changes and sunset clauses.
- Product liability: Support in the field of manufacturers' liability for product defects, compliance with product safety regulations, and representing Clients in consumer claims and product damage proceedings.
- Medical law and healthcare: Providing legal consultancy to healthcare providers, assisting in the registration of healthcare entities, drafting bylaws and internal procedures, and advising on medical error risk management.
- Representation before regulatory authorities: Representing Clients before the Patent Office of the Republic of Poland (UPRP), the European Union Intellectual Property Office (EUIPO), the World Intellectual Property Organization (WIPO) and other regulatory bodies.
- Consultancy in the area of advertising and product promotion: Development of advertising strategies in compliance with legal regulations, consultancy in the area of product labeling and conducting health promotion.
- Support in the establishment and operation of healthcare business activity: Registration of healthcare entities, preparation of bylaws and internal procedures, and consultancy in the area of management of healthcare business activity.
- Internal procedures and audits: Development of internal regulations and procedures, conducting compliance audits, and assessment of legal risks.
- Corporate and investment support: Consultancy in the scope of day-to-day corporate operations, M&A transactions, and entering into investment agreements.
- Support for research and development (R&D) projects: Legal advice on R&D cooperation, including transfer of technology and innovation.
- Regulatory consultancy: Support in obtaining permits and licenses, representation before regulatory authorities, and consultancy in the area of compliance with product marketing regulations.
- Litigation: Representing Clients in litigation and arbitration proceedings, both domestically and internationally.
- Consultations and education: Organization of training courses, workshops and legal consultations on the regulation of medicinal products, medical devices, cosmetics and food, as well as product liability and regulatory compliance.
WHY US?
- Expertise and commitment: Among other things, members of the team are involved in the work conducted by the Ministry of Development and Technology on the draft law on the cosmetology specialist profession.
- Journalistic speeches and lectures: Members of the team are authors of papers and speakers at numerous industry and media conferences on the regulation of the aesthetic and cosmetic market.
- International cooperation: The Life Sciences & Biotechnology team cooperates with regulatory and registration representation in Brussels and has many years of experience collaborating with entities and associations from Europe (including the EU), the US and Asia.
- Involvement of partners: The partners are directly involved in each project, which ensures the highest quality of service and substantive support at every stage of cooperation.
