REGULATORY AFFAIRS
Medicinal Products, Medical Devices, Cosmetics and Food Supplements
Consultancy - Registrations, Variations, Renewals Applications - eCTD
General
- Provision of advice and handling of Regulatory Affairs issues regarding Pharmaceuticals, Medical Devices, Food Supplements, Cosmetics
- Ensure the compliance of Client’s Pharmaceutical and other products with the current regulations, laws, and guidelines during their life-cycle
- Development of standard Operational Procedures in accordance to GDPR, GCPs, GMPs
- Development of Presentations and Trainings regarding RA issues
Pharmaceuticals
- Coordination and handling of all activities referred to the registration and life-cycle management of marketing authorizations of medicinal products
- Advice and guidance on registration procedures
- Preparation and Submission of Marketing Authorization Applications through National, MR and DC procedures to EOF and EU agencies
- Preparation of the Module 3 of the dossier for National, MR and DC procedures
- Preparation and Submission of variation and Renewals through National MR and DC procedures
- Preparation of the e-CTD dossiers
- Provision of accurate translations of Product Information documents (SPC, PIL, Labeling), training materials, promotional materials, Artworks and packaging materials
- Creation and Review of the text for Artworks, Packaging Materials, Promotional Materials
- Preparation and Submission of withdrawal applications
- Preparation and Submission of transfer applications
- Support in any other RA activity related to medicinal products
Food Supplements
- Registration of the Food Supplement to EOF
- Preparation of the product notification file
- Creation and review of Greek labeling texts
- Support in any other RA activity related to food supplements
Medical Devices –
In Vitro Diagnostics
- Registration of the Medical Device to EOF database
- Registration of the manufacturer / producer / importer to the relative authority
- Creation and review of Greek labeling texts
- Support in any other RA activity related to medical devices – in vitro diagnostics
Cosmetics
- Registration of the Cosmetic product to the responsible agency
- Registration of the manufacturer / producer / importer to the responsible agency
- Creation and review of Greek labeling texts
- Support in any other RA activity related to Cosmetic products