Monika Duszyńska

Monika specialises in regulatory matters, pricing and reimbursement, promotion, distribution, and manufacturing of pharmaceuticals and medical devices.

Her expertise also includes intellectual property, where she drafts and negotiates licensing agreements for medicines, trademarks, know-how, and copyrights, as well as R&D and clinical trial agreements. She provides counsel on compliance and transparency requirements, particularly regarding industry relations with healthcare professionals and patient organisations. Monika also conducts compliance audits and assists clients in compliance-related criminal investigations.

She has advised on M&A transactions involving companies manufacturing medicinal products, medical devices, dietary supplements, and veterinary products.

She has represented clients before regulatory agencies and courts.

Monika speaks English, French, Italian, Spanish, Russian, and basic Chinese.

Monika has been advising pharmaceutical and medical device companies since 1999. For 15 years, she worked at major law firms, including three years as a Partner at CMS Cameron McKenna, co-heading the Life Sciences practice in CEE. She holds a Master's in Law and a Master's in Italian Language.

Monika has contributed to numerous publications on reimbursement, biosimilars, drug substitution, pharmaceutical advertising, medical cannabis, orphan drugs, early access to innovative therapies, and reasons for the limited availability of certain treatments (including five scientific publications issued by Lazarski University).