Regulatory Affairs and Quality – comprehensive services in the Nordic countries

Do you need a Nordic Regulatory Expert? Our service-oriented Regulatory Affairs Specialists are here to help you throughout the life cycle of human and veterinary medicines. We know that you often face challenging schedules, and we are ready to help you even at short notice without making compromises on quality. From single projects to fully outsourced activities – please contact us for further information!

• Marketing authorisation applications and maintenance (e.g. variations, renewal applications, applications for transfer of a marketing authorisation to a new holder and OTC applications) for human and veterinary medicines
• Preparing, translating and updating product information texts (SmPCs, PLs and labelling) and patient support materials
• Updating pharmaceutical databases (e.g. Pharmaca Fennica, Lääkeohje, FASS, Felleskatalogen)
• Pharmaceutical chemical expert services (e.g. writing and updating module 2.3 and 3 texts and IMPD documentation)
• Regulatory review of texts related to herbal products, dietary supplements, cosmetic products and medical devices
• Introduction to market and shortage notifications
• Handling of product complaints, QA tasks