Service 01
Regulatory Affairs
Strategy, submissions and lifecycle maintenance across pharmaceuticals, medical devices, cosmetics, food supplements and biocides.
What it covers
Across every regulated category
Pharmaceuticals
- Regulatory strategy
- CMC strategy
- In country level regulatory support
- Regulatory Affairs project management
- Regulatory application preparations and submission (EU/non-EU territories)
- Dossier compilation
- Interim Regulatory support
- Lifecycle management of the marketing authorization
- Labelling and artwork compliance
- Global Medical writing
Medical Devices
- Compilation and review of product’s notification dossier.
- Submission of product’s notification application to CYMDA.
- Preparation of Greek/English labelling texts and Instructions for Use.
Cosmetics
- Local importation requirements
- Dossier compilation
- Preparation of labelling texts.
Food Supplements
- Collection and review of product’s notification dossier.
- Submission of product’s notification and distribution application to Medical and Public Health Services.
- Preparation of Greek labelling texts and Instructions for Use.
Biocides
- Regulatory strategy
- EU and local country level regulatory support
- Project management
- Regulatory application preparations and submission
- Dossier compilation
- Labelling and artwork compliance