Pages

Scandinavian Regulatory Services


Regulatory Procedures


Typical services we provide include the following:

Medicinal products:

  • Clinical trial submission
  • MA submissions
  • National submissions
  • Mutual Recognition Procedures
  • Decentralised procedures
  • Centralised procedures
  • Orphan Medicinal Products
  • Dossier preparation / compilation

Medical Devices:

  • Clinical trial submission
  • Device classification
  • CE marking of Class I + IIa + IIb + III devices
  • CE-marking of IVDs (In-Vitro-Diagnostics)
  • Selection of and communication with Notified Body
  • Dossier / Technical File preparation

Cosmetics:

  • Labelling
  • Dossier preparation
  • Liaise with Agencies

Food supplements:

  • Food safety assessments – EFSA procedures

Border Line Products:

  • Classification discussions


This is a list of typical procedures we support. Please feel free to contact us to discuss your needs.

MARKET ACCESS