News 18 June 2015

PrimeBioMed is Ready to Start Exporting Products to Europe

Portfolio companies of PrimeBioMed RVC Biofund has certified the quality management system in compliance with international standard ISO 13485. This officially confirms compliance of its operating procedures, quality of products, processes and systems with international legal requirements and additional voluntary standards. The audit was performed by experts of the German company BSI Group Deutschland GmbH. The certificate is valid for 3 years. The international quality certificate is not only a significant competitive advantage in the Russian market, but also opens up opportunities for exports. The company's plans for 2015-2016 include bringing its products to the international market. Currently, they are negotiating with medical centers in Italy and Switzerland.

PrimeBioMed has been working in the Russian market since 2014. It is currently the only Russian laboratory specialized in development and production of antibodies for IHC diagnostics of neoplastic diseases, which has a quality control system that meets international standards.

Russian clients of the company include Research Institute of General Pathology and Pathophysiology, N.N. Blokhin Russian Cancer Research Center, Avicenna Medical Center, Tomsk Scientific Research Institute of Oncology, St. Petersburg Clinical Research Center of Specialized Care (Oncology), and others.

Products by PrimeBioMed have a lower price in comparison with Western analogues while preserving high quality standards since the Russian "address" allows to optimize the costs associated with delivery and to simplify the accounting statements, and the absence of customs clearance not only saves funds but also time for promotion of products on the market.

Alexey Grachev, CEO, PrimeBioMed LLC, said,

"The ISO13485 certification is the further proof that Russia can create and does create world-class innovative companies. I hope that this certificate will open up for our company new opportunities not only in Russian market but also in the European one."