Maria Samolińska

Partner | maria.samolinska@blsklegal.com |

Partner. A pharmacist and former government pharmaceutical inspector who has spent the past two decades building an innovative healthcare practice. A versatile advisor, she supports clients both in planning strategies for the manufacture, distribution and marketing authorisation of medicinal products, and in managing crisis situations, including cases of quality defects or irregularities identified during inspections.

EXPERIENCE

Preparing applications for permits to operate a pharmaceutical wholesaler, a manufacturing plant or to import medicinal products, and conducting related proceedings before the Chief Pharmaceutical Inspector or the Chief Veterinary Officer.
Preparing for GMP and GDP inspections, conducting audits at manufacturers and distributors in preparation for certification.
Conducting proceedings related to quality defects of medicinal products; auditing contract manufacturers.
Developing models for the manufacture of medicines in Poland and worldwide, including audits, agreements, obtaining permits and certificates.
Preparing and reviewing distribution models for medicinal products; drafting and negotiating agreements.
Notifications of dietary supplements and food products; representing clients before the Sanitary Inspection and the Trade Inspection for Agricultural and Food Quality.
Advertising of medicinal products, medical devices and dietary supplements.
Supporting clients in the process of registration of medicinal products.