Consulting for the Life Sciences industry

Life Sciences

Our approach

We combine legal, tax, and technological expertise to effectively support life sciences companies in their growth and innovation implementation. Our interdisciplinary approach allows us to handle both day-to-day operational processes and strategic projects. With extensive experience in interactions with supervisory authorities, we guide clients through inspections, certifications, and crisis situations.

For whom?

Benefits

Our advisory services help innovative entrepreneurs grow safely in a world of increasing regulations, protect intellectual property, and build lasting relationships with partners and institutions.

Efficient Market Entry for Products

We prepare and negotiate agreements related to clinical trials, production, distribution, and wholesale and retail sales of life sciences products. We support product qualification processes and obtaining the necessary manufacturing and marketing authorizations.

Effective Intellectual Property Protection

We advise on patents, trademarks, software, and technology transfer, safeguarding key assets of biotech, pharmaceutical, and medtech companies.

Secure Collaboration with Partners and Institutions

We design contracts, support inspections and proceedings, minimizing legal and reputational risks in domestic and international relations.

Services

We support life sciences companies in a dynamic regulatory and technological environment. We advise pharmaceutical manufacturers, biotech firms, medtech companies, and healthcare entities, helping them safely develop innovations, bring them to market, and protect their most valuable assets.

Market entry / regulatory affairs

We provide support in the registration and marketing authorization processes for drugs and medical devices. We assist in obtaining permits and meeting regulatory requirements (including GDP, pharmacovigilance). We help ensure proper product labeling, compliance of advertising and marketing activities with pharmaceutical law, and oversee patient safety processes.

We support clients in discussions with government representatives and EU authorities regarding European product classification standards and prepare opinions on regulatory changes.

Contracts / business partnerships

We support clients in discussions with government representatives and EU authorities regarding European product classification standards and prepare opinions on regulatory changes.

Intellectual property and innovation

We protect innovations in biotechnology, pharmaceuticals, and medtech. We advise on patent protection, trademarks, bioinformatics software, and AI algorithms. We represent clients in disputes concerning counterfeits, patent infringements, and acts of unfair competition. We secure key patent licenses across jurisdictions and support technology transfer and commercialization of research results.

Data protection and cybersecurity

We offer advisory services on processing sensitive data, particularly patient and medical data. We advise on data transfers in clinical trials, implementation of GDPR procedures, incident response, and communication with the Data Protection Authority (UODO). We handle breach cases, ensuring minimization of legal and reputational risks.

Competition and consumer protection in Life Sciences / marketing and advertising law

We help ensure lawful advertising of drugs and medical devices, eliminate risks of unfair practices, and represent clients in proceedings before the Office of Competition and Consumer Protection (UOKiK). We develop safe loyalty programs.

Pharmaceutical law and regulatory compliance

We support pharmaceutical companies, biotech firms, and drug wholesalers in areas such as GDP, GMP, and pharmacovigilance. We advise during inspections by GIF, PUODO, or UOKiK, prepare internal procedures, and review contracts related to the transport and storage of medicinal products, ensuring compliance with applicable regulations.

Labor law and HR

We advise on labor law matters in healthcare entities and pharmaceutical companies. We structure and support the hiring of key specialists, provide documentation protecting trade secrets, confidential information, non-compete clauses, etc.

M&A and succession

We advise on mergers and acquisitions in the pharmaceutical and biotech sectors, including regulatory and IP due diligence. We also support succession planning for family-owned businesses operating in the life sciences field.

ESG and non-financial reporting

We assist life sciences companies in implementing ESG strategies, preparing reports compliant with CSRD and ESRS, and identifying materiality indicators. We help develop environmental, social, and governance policies tailored to the industry’s specifics.

Training

We conduct tailor-made workshops for the life sciences sector — covering pharmaceutical law, personal data protection, compliance, executive liability, regulatory risk management, and crisis response. These workshops equip our clients’ teams with the competencies necessary for safe and effective business operations.

team