Pages

Scandinavian Regulatory Services

Regulatory Procedures

The 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

Medical Devices:

•Clinical trial submission
•Class I + IIa + IIb + III submission
•Liaise with NB
•Dossier preparation

Cosmetics

•Labelling
•Dossier preparation
•Liaise with Agencies

Chemicals

•Labelling
•Liaise with Agencies

Food supplements

•Food safety assessments – EFSA procedures

Please feel free to contact us to discuss what with can assist you with.

DEVELOPMENT SERVICES