The certification covers the development, production and sales of soluble beta-glucans for its advanced wound treatment product Woulgan Biogel.
The product’s quality management system has been certified under the EN-ISO 13485:2012/ ISO 13485:2003 standard by Det Norske Veritas.
Biotec Pharmacon CEO Svein Lien said, "This certification is an important step in our efforts to get this novel product CE-marked for Europe by the end of the first half year of 2013, and a substantial achievement for a small company like ours."
In 2012, the company has filed for approval of Woulgan Biogel as a medical device with DNV-Presafe as notified budy.
The product, which has SBG incorporated as an ancillary medicinal substance, is being reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
