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Regulatory Affairs

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)

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