Regulatory Affairs Mericon AS - A Norwegian CRO - has many years of experience in assisting pharmaceutical industry in regulatory affairs management. We can offer help/assistance at all levels in the regulatory affairs management. Regulatory Affairs Services: · Assist in contact with The Norwegian Medicines Agency (NoMA). · Provide guidance according to national procedures and requirements. · Translate Product Characteristics (SPC). · Translate Patient Information Leaflet (PIL) and labelling. · Translate other relevant documents related to marketing authorisation. · Readability test of package leaflet. · Assist regarding submission of variation to NoMA. · Prepare and update product information in The Norwegian Pharmaceutical Product Compendium (Felleskatalogen). · Ensure health and public marketing information is provided according to Norwegian law.