About
EAST PHARMA is a Romanian GDP-authorized pharmaceutical wholesaler built for licensed B2B partnerships.
Established in 2018, EAST PHARMA supports licensed EU pharmaceutical partners with sourcing, distribution, and parallel export coordination in Romania. We combine local market understanding, controlled execution, and clear documentation within a regulated wholesale environment.
We give European pharmaceutical companies a compliant route into the Romanian market, supported by the documentation, infrastructure, and regulatory awareness required for regulated activity.
GDP in practice
Good Distribution Practice governs how we store, handle, document, and distribute medicinal products. It supports product quality, integrity, traceability, and process control across distribution activity.
Our premises, equipment, and operating conditions are maintained in line with GDP requirements for the storage and distribution of medicinal products. Our operations are subject to the Romanian regulatory framework applicable to pharmaceutical wholesale activity, under the oversight of the National Agency for Medicines and Medical Devices of Romania (NAMMDR).
Our Wholesale Distribution Authorisation and GDP certificate are publicly listed in the EudraGMDP database maintained by the European Medicines Agency, where current authorization records can be checked.
Further information relevant to partner qualification is available on our authorizations and GDP compliance page.
Responsible Person
EAST PHARMA operates under the oversight of a qualified Responsible Person appointed in line with EU pharmaceutical wholesale distribution requirements.
The Responsible Person oversees ongoing GDP compliance across distribution activity and serves as the primary regulatory contact.
For compliance inquiries: info@east-pharma.com
Quality Management System
EAST PHARMA maintains a Quality Management System aligned with EU Good Distribution Practice requirements.
Our QMS is built around 24 documented standard operating procedures covering all GDP-critical areas, from supplier qualification and deviation management to personnel training, product recall, and IT system validation.
Falsified Medicines Directive (FMD)
EAST PHARMA operates in line with the requirements of the Falsified Medicines Directive and EU serialisation rules for medicinal products.
This includes active verification of partners and transactions through the Romanian national serialisation system (SNVM).
