Optimal resource efficiency and quality in regulatory life cycle management in the Nordics

Do you need a partner for regulatory life cycle management in the Nordic countries? Our service-oriented team of experts is ready to tackle your challenges in regulatory affairs, pharmacovigilance and medical information and will provide high-quality translations into all Nordic languages. We know the tight schedules you are facing and are ready to help you even at short notice without making compromises on quality. From single projects to fully outsourced activities – we look forward to hearing from you!

Regulatory affairs

  • Marketing authorisation applications and maintenance (e.g. variations, renewals, transfer applications and OTC applications) for human and veterinary medicines
  • Translation and preparation of and updates to product information texts (SmPCs, PLs and labelling) and patient support materials
  • Pharmaceutical Chemical writing (e.g. writing and updating module 2.3 and 3 documents, IMPD)
  • Registration of herbal products, dietary supplements and cosmetic products
  • Translation and ethical and medical review of promotional materials

Pharmacovigilance

  • Local affiliate pharmacovigilance obligations, such as Adverse Event receipt and processing, monitoring of local medical literature, internet and digital media screening, pharmacovigilance training and administrative work, including reconciliations, compliance monitoring and deviation reporting
  • Coaching for audits and inspections and assisting in meetings with authorities
  • Planning and preparation of local pharmacovigilance quality documents
  • Translation of texts related to pharmacovigilance

Medical information

  • Managing medical information functions for pharmaceutical and medical device companies, utilising our experience as the leading medical information centre in the Nordics
  • Service is provided in Finnish, Danish, Norwegian, Swedish and English via phone, e-mail or chat

 Medical and pharmacological translations

  • Medical texts including product information texts, patient support material, texts related to pharmacovigilance and clinical trials, pricing and reimbursement applications, health economic reports, and promotional materials
  • All the Nordic languages, English and several other languages including Russian
Laura Riihimäki-Lampén

Laura Riihimäki-Lampén

Head of Regulatory Affairs and Translations
Phone Icon +358 50 409 9161
Jennie Tjernström

Jennie Tjernström

Key Account Manager
Phone Icon +46 70 918 45 52
Päivi Väänänen

Päivi Väänänen

Account Director
Phone Icon +358 50 533 8559