About us

Founded in 2014, Biodrug s.r.o. is a European pharmaceutical company acting as a Marketing Authorisation Holder (MAH) and a trusted partner for licensing, regulatory affairs, pharmacovigilance, commercialization, and distribution of human medicinal products. With extensive experience across Central and Eastern Europe (CEE), we help pharmaceutical companies successfully introduce, expand, and manage their products in European markets.

Our expertise covers vaccines, antibiotics, anti-infectives, immunoglobulins, blood derivatives, biosimilars, medical devices, and other specialty medicines. We provide integrated support throughout the product lifecycle—from licensing and market entry to regulatory maintenance, pharmacovigilance, distribution, and commercial development.

By combining scientific expertise, regulatory excellence, and practical market knowledge, we deliver tailored solutions that help our partners navigate complex regulatory environments while accelerating market access and long-term commercial success.

Quality, compliance, transparency, and patient safety are at the heart of everything we do. Through close collaboration with our partners and health authorities, we ensure that every project is managed to the highest regulatory and ethical standards.

At Biodrug, we believe successful partnerships are built on trust, responsiveness, and shared ambition. Our mission is to improve patient access to medicines while creating sustainable value for our partners across Europe.

Biodrug's approach to business ethics is built on transparency, accountability, and respect for applicable laws, regulations and industry standards. We act responsibly in the management of medicinal products and maintain fair, ethical cooperation with partners, authorities and stakeholders.

Biodrug maintains internal processes and controls that support patient safety, product quality, pharmacovigilance obligations and safety oversight. We also place strong emphasis on data protection, confidentiality, responsible promotion, commercial practices, supply chain integrity and distribution standards. 

We expect our partners, suppliers and collaborators to follow comparable ethical and compliance standards. Responsible business conduct is an essential condition for sustainable cooperation and longterm partnership.

Biodrug's Code of Conduct defines the principles and rules that guide our business behaviour. It applies to employees, management and relevant third parties involved in activities under Biodrug's responsibility.