Publisert 01.06.2016

Regenics signs CE marking consultancy agreement with Haflan Resources AS

Regenics AS signs on EU medical device consultancy agreement with Haflan Resources AS.

Regenics has agreed to work closely with Haflan Resources AS; a leading expertise in European Medical Device CE marking quality systems for Regenics wound healing device Vernex®.

Haflan starts working with the compilation of the Vernex® dossier scheduled for submission in 3q 2018 following the approval of the clinical safety study REG002 by REK (The Regional Ethical Comittee on April 7th and June 9th 2016. 

CEO Henrik Lund says: "We are very pleased to have started the collaboration with Haflan Resources AS. Expertise in the complex regulatory aspects of CE marking is beuracratic and sometimes challenging and an area where SMEs really gets value for their efforts spent. Haflan will oversee both our internal quality systems as well as the actual dossier compilation and due progress." 

Haflan contacts:

Haflan Resources, Lofthusveien 29, 0588 Oslo, Norway

Tel: +4797683900


Support and collaboration partners:

Regenics AS have developed clinical proof of efficacy and safety  in human 2 degree burn wounds for our products Collex® and Vernex®.

The procudts are beeing developed as class III devices. WoundClear® is developed as a BLA/EU CP biotech drug.