Highlights of our experience in Lifesciences in Poland

• A leading global medical device and pharmaceutical company on regulatory issues concerning both medical devices and medicinal products, in such areas as compliance, reimbursement, marketing, promotion and distribution.
• Numerous pharmaceutical companies on strategic projects comprising complex compliance issues, including identifying risks and proposing an entirely new model of business organisation. Providing a general review of the client’s educational and marketing strategies, as well as a complex audit of relevant documentation.
• Recordati on the acquisition of Farma-Projekt, a Polish pharmaceutical company.
• A UK listed pharmaceutical company on regulatory and nuclear requirements for placing a medical device containing radioactive isotopes on the Polish market. Our advice covered the regulatory obligations for medical devices, nuclear safety requirements and authorisations for radioactive products, as well as the obligations of hospitals which intend to administer/use radioactive products in Poland.
• An American oncology company on regulatory issues regarding orphan medicinal products and other legal matters, as well as coordinating work in a number of CEE jurisdictions.
• Henry Schein Inc. on the acquisition of shares in Medivet S.A., the provider of animal health products.

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