10+ years experience in CEE as trusted Partner

Reliable pharmaceutical distribution International pharmaceutical shipping aligned with pharma guidelines and cross-border requirements Protecting patient safety through pharmacovigilance excellence. CEE market entry with strategic launch support Trusted MAH and distribution partner ensuring regulatory compliance and smooth operations Your Central European specialty pharma partner Together for better health Licensing-driven regulatory and commercial partner for medicinal products

About us

Since 2014, Biodrug s.r.o. has been helping pharmaceutical companies successfully bring human medicinal products to market. We provide integrated licensing, regulatory, pharmacovigilance, market access, commercial and distribution support, with particular expertise across Central and Eastern Europe (CEE).

Our combination of regulatory excellence and commercial insight enables clients to navigate complex markets efficiently while ensuring compliance throughout the product lifecycle. Whether launching a new product, expanding into new territories, or maintaining an existing portfolio, we deliver practical solutions tailored to your business goals.

Proven MAH experience and regulatory accountability
Extensive expertise across CEE pharmaceutical markets
Integrated regulatory and commercial approach
Reliable, long-term partnerships built on trust and compliance

Learn more about us

10+

Years of Experience

Our services

Integrated services for successful market entry and commercialization

Licensing & Partnership

We build long-term partnerships with manufacturers, biotech companies and marketing partners seeking access to Central and Eastern European markets.

Distribution & Sales

We support the compliant distribution.

Regulatory affairs

We support marketing authorisation, registration and ongoing regulatory compliance of medicinal products throughout their lifecycle in Europe.

Pharmacovigilance

We ensure compliant pharmacovigilance systems that safeguard patient safety and fulfil MAH regulatory obligations.

Commercial & Market Access

We support partners in navigating regional market and reimbursement environments to enable sustainable product presence and growth. and commercial execution of medicinal products through established partner networks