Our team Lawyers specialising
Whole team
Lawyers specialising
in Life Sciences
We translate complex pharmaceutical and food regulations into practical solutions. We support clients at every stage of their business – from planning and obtaining authorisations to certification and audits.
We identify potential risks and minimise them effectively – both in day-to-day operations and in crisis situations.
Strategic Advice
Support in short- and long-term planning of business management and product development. Medicine distribution models in Poland and global markets, parallel importers in the EU, import of medicines for rare diseases.
Legal Analyses and Opinions
Detailed legislative analyses and reports on the practice of Polish regulators. Legal opinions that apply the regulations to specific facts and set out possible courses of action.
Medicinal Products
Regulatory advice at every stage: research (R&D, clinical trials), registration procedures, placing on the market, post-authorisation variations and compliance monitoring. Support with product suspensions and withdrawals.
Audits
Quality audits at pharmaceutical manufacturers and wholesalers assessing regulatory compliance. Carried out at the client’s premises or on its behalf at subcontractors and contract manufacturers – in Poland, the EU, Asia and North America.
Legal Proceedings
Representing clients before administrative and common courts. Cases concerning regulated activities (authorisations, licences, post-authorisation proceedings, registration and reimbursement), customs, tax and environmental matters.
Food and Dietary Supplements
Support for businesses placing food or dietary supplements on the market. Dealing with regulators, reviewing product composition, labelling and advertising, and proceedings before the sanitary inspection authorities.
We advise at every stage – from R&D and clinical trials, through registration and distribution, to crisis situations and contentious proceedings.
Audits on 4 continents
Experience in GMP audits in Poland, EU countries, Asia and North America.
The full regulatory cycle
From R&D and clinical trials, through registration and distribution, to post-authorisation variations and product withdrawal.
Across the market
We work with manufacturers, parallel importers, wholesalers, distributors and marketing authorisation holders.
We talk to the point, without unnecessary formalities. Call or write – we arrange meetings in person and online.
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