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Regulatory Affairs


  • Mari
  • Mari Ala-Opas
  • Head of Regulatory Affairs
  • On maternity leave
  • Anne-Mari
  • Anne-Mari Koskela
  • Manager - Regulatory Operations
  • 040 505 3852
  • Päivi
  • Päivi Mannervuori
  • Senior Regulatory Affairs Specialist
  • 010 4398 222
  • Tuire
  • Tuire Skinnari
  • Pharmacovigilance, Regulatory Affairs Officer
  • 010 4398 222
  • Terhi
  • Terhi Majava
  • Pharmacovigilance, Regulatory Affairs Officer
  • 010 4398 251
  • Eliisa
  • Eliisa Ketopaikka
  • Regulatory Affairs Officer
  • 010 4398 241
  • Laura
  • Laura Nevala
  • Coordinator for Marketing Authorizations
  • 010 4398 253
  • Johanna
  • Johanna Kytöluoto
  • Coordinator for Marketing Authorizations
  • 010 4398 222
  • Johanna
  • Johanna Oinonen
  • Regulatory Affairs Assistant
  • 010 4398 222
  • Maija
  • Maija Saarenpää
  • Regulatory Affairs Assistant
  • 010 4398 222

Head of Department, Ms Mari Ala-Opas, M.Sc. (Pharm.)

Total ten years of experience in Drug Regulatory Affairs as Coordinator for Marketing Authorizations at the Finnish Medicines Agency (FIMEA), as Regulatory Affairs Manager at Pfizer Oy and at Novartis Finland Oy including a 6-month secondment at Novartis Pharma AG, Basel Switzerland.

Manager - Regulatory Operations, Ms Anne-Mari Koskela, M.Sc. (Pharm.)

Over 11 years of experience in Drug Regulatory Affairs as Coordinator for Marketing Authorizations at the Finnish Medicines Agency (FIMEA), as Project Manager for MRP at the Medicines and Healthcare products Regulatory Agency (MHRA) in London and as Regulatory Affairs Manager at Pfizer Oy.

Services:

  • applications (marketing authorizations, marketing authorization transfers, variations, renewals, OTC)
  • overall product responsibilities
  • database updates
  • proof reading
  • preparation and evaluation of pharmaceutical documentation
  • training and coaching
  • meetings with authorities
  • review of promotional materials

For more information, please contact our Sales Director:

Mika Pulkkinen
mika.pulkkinen[a]farenta.fi
+358 (0)10 4398 233