Regulatory Affairs Consulting

Services Overview

• Registration of Food supplements

• Registration of Borderline products

• Registration of Medical devices

• Registration of Medicinal products

• Regulatory strategy advisory services

• Variation submissions/notifications

• Assessment of documentation for registration/dossier

• Preparation of registration documentation according to Macedonian Health Authorities requirements (translations where necessary)

• Coordinating and active communication with the eCTD/dossier owner till finalization of the registration procedure and MA/permission grant

• Trademark / Brand Name registration

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