Our Regulatory Affairs Team has extensive experience in providing regulatory support in the European Union and Abroad. Our Human Medicines services involve Pre-submission and Post-approval procedures, while we also engage, with great success, in Medical Devices, Cosmetics and Food Supplements Regulatory Affairs.
Human Medicines
Pre-submission
- Consulting on Regulatory Procedures & Submission Strategy
- Evaluation of Product Submission Dossier
- Dossier Compilation & Submission to Regulatory Authorities for Marketing Regulatory Submissions through:
- National Procedures (MAA)
- Mutual Recognition Procedures (MRP)
- Decentralized Procedures (DCP)
- Centralized Procedure (CP) including module 1 preparation
Post-approval
- Regulatory Support & Submissions (Variations, Renewals)
- Adaptation & Translation of Product Information (SmPC, labelling & PIL) according to QRD Templates
- Artwork Review
- Other Regulatory Translation Services
- Authorities Interfacing
- Pricing &Market Access
Medical Devices
- Advice on current legislation in Europe and Greece in relation to medical devices
- Assistance with the submission of clinical trials to the competent authorities and Ethics Committees, together with the related consulting activities
- Assuming the role of Authorized representative (direct contacts with the competent authorities of the EU and management of post-marketing surveillance)
- Contracts with Notified Bodies and consultancy for obtaining CE marking
- Contracts with qualified laboratories to conduct tests on devices
- Notification of medical devices into the database of the Ministry of Health and in the relative databases of the other countries belonging to the EEA Agreement zone
- Preparation of technical dossiers in order to obtain the CE mark
- Preparation of documents required for Class I devices
- Preparation of advertising material and, if necessary, the preparation of applications for authorization
- Regulatory activities regarding the import/export of medical devices
- Registration of manufacturers of custom-made devices
- Verification of compliance of the document accompanying medical devices for customs authorities
Cosmetics
- Consulting for manufacturers of cosmetic products in order to comply with the new provisions of Regulation (EC) no. 1223/2009
- Cosmetovigilance
- Control of cosmetic packaging
- European Central Notification and Code obtaining
- Preliminary examination of printed material and verification of compliance with applicable regulations
- Verification of documents that accompany imported cosmetics such as certificates of analysis, batch records, lists of ingredients
Food Supplements
- Assistance for imports from European countries
- Assistance in the preparation of technical and administrative documents for export to Europe and non-EU countries
- Assistance with the process of phytovigilance
- Check of packing materials
- Formulation of new products and / or reformulation of products already on the market
- Identification of claims that can be used
- Preliminary examination of the text of labels and verification of their compliance with current regulations
- Preparation of brochures and leaflets
- Process for notification to the Ministry of Health
- Request for Certificates of Free Sale (CLV)
