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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


  1. Consulting on Regulatory Procedures & Submission Strategy
  2. Evaluation of Product Submission Dossier
  3. Dossier Compilation & Submission to Regulatory Authorities for Marketing Regulatory Submissions through:
    1. National Procedures (MAA)
    2. Mutual Recognition Procedures (MRP)
    3. Decentralized Procedures (DCP)
    4. Centralized Procedure (CP) including module 1 preparation


  1. Regulatory Support & Submissions (Variations, Renewals)
  2. Adaptation & Translation of Product Information (SmPC, labelling & PIL) according to QRD Templates
  3. Artwork Review
  4. Other Regulatory Translation Services
  5. Authorities Interfacing
  6. Pricing &Market Access

Medical Devices

  1. Advice on current legislation in Europe and Greece in relation to medical devices
  2. Assistance with the submission of clinical trials to the competent authorities and Ethics Committees, together with the related consulting activities
  3. Assuming the role of Authorized representative (direct contacts with the competent authorities of the EU and management of post-marketing surveillance)
  4. Contracts with Notified Bodies and consultancy for obtaining CE marking
  5. Contracts with qualified laboratories to conduct tests on devices

  1. 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
  2. Preparation of technical dossiers in order to obtain the CE mark
  3. Preparation of documents required for Class I devices
  4. Preparation of advertising material and, if necessary, the preparation of applications for authorization
  5. Regulatory activities regarding the import/export of medical devices
  6. Registration of manufacturers of custom-made devices
  7. Verification of compliance of the document accompanying medical devices for customs authorities


  1. Consulting for manufacturers of cosmetic products in order to comply with the new provisions of Regulation (EC) no. 1223/2009
  2. Cosmetovigilance
  3. Control of cosmetic packaging
  4. European Central Notification and Code obtaining
  5. Preliminary examination of printed material and verification of compliance with applicable regulations
  6. Verification of documents that accompany imported cosmetics such as certificates of analysis, batch records, lists of ingredients

Food Supplements

  1. Assistance for imports from European countries
  2. Assistance in the preparation of technical and administrative documents for export to Europe and non-EU countries
  3. Assistance with the process of phytovigilance
  4. Check of packing materials
  5. Formulation of new products and / or reformulation of products already on the market
  6. Identification of claims that can be used
  7. Preliminary examination of the text of labels and verification of their compliance with current regulations
  8. Preparation of brochures and leaflets
  9. Process for notification to the Ministry of Health
  10. Request for Certificates of Free Sale (CLV)

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