Regulatory Affairs

Regulatory Services


Our In-house Regulatory Affairs department meets your needs within the wide area of Regulatory Affairs. We have long experience in all aspects of regulatory, pharmacovigilance, QA, medical translations. The In-house department is headed by Helena Björkman with 20 years of experience in the regulatory field, last 10 as a senior executive and with the network that you need.

PharmaRelations provide a wide range of regulatory services; e.g. FASS, Felleskatalogen, Pharmaca Fennica, DKMA-net, vnr, LiiV, Farmalogg, translations into Swedish and Norwegian, mock-ups and labelling, variations and renewals, QC checks, coordination, database maintenance, classification, OTC-switches, new applications, regulatory strategies, medical writing, audits, CMC-support and regulatory intelligence from an ever-changing pharmaceutical landscape. We can act as your local Regulatory Affairs Department or we support your first steps on the Nordic markets. PharmaRelations provide a custom-made flexible solution for your needs; part-time, full-time, long term, short term, peaks, projects and Ad-hoc solutions to allows you to focus and get results as quickly as possible.

The Nordic Regulatory Affairs Partner

•Insourcing and outsourcing of regulatory consultants or recruitment of regulatory staff

•Flexible, efficient and high quality services

•Nordic partner - Offices in Stockholm, Copenhagen, Helsinki and Oslo

•Deep knowledge of the local Swedish and Nordic regulatory landscape

•PharmaRelations has a long experience and knowledge from working within the pharmaceutical industry


To find out more about our services and solutions please contact;

Helena Björkman, Head of Regulatory Affairs
Phone: +46 (0)8-120 122 77
Mobile: +46 (0)70-165 22 77