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
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