Regulatory affairs

Vistor boasts an all-out support division of specialists in regulatory affairs and translators of pharmaceutical texts with extensive experience. The Regulatory Affairs Department oversees communications with medicines authorities on behalf of Vistor’s principals regarding applications for and maintenance of Icelandic marketing authorizations. This includes, among others, comprehensive translation services for all texts included in submissions for marketing authorisations, i.e. summaries of product characteristics, patient information leaflets, instructions for use, and package labelling. The department also reviews marketing materials for Vistor’s marketing departments upon request by marketing authorisation holders. 

The department operates according to the most rigorous requirements set forth by both suppliers and regulatory authorities. Our Specialists in Regulatory Affairs are committed to working in compliance with current laws and regulations, according to the Regulatory Affairs Department’s internal quality system, and to preserve and protect public health. It is our duty to abide by our commitments at all times, be trustworthy, accurate, and fair towards all stakeholders.

Please contact department Manager, Brynju Dís Sólmundsdóttur brynjaso@vistor.is for further information.