OP Pharma

Regulatory Affairs Outsourcing and Consulting

Young and dynamic society

Dr. Osvaldo Ponchiroli

Performance, Services, Digital Regulatory

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Regulatory Practices

Customer Support , preparation and sending:

  • Submissions and follow-up until the conclusion of national and European procedures;
  • Variations (including definition of the type and sharing of the regulatory strategy);
  • CESP Submissions;
  • Renewals;
  • Renewals;Transfers of MA ownership, Deletion on Marketing (DoMa);
  • Prices and negotiation with IT Health Authority AIFA;
  • Publication on the Official Gazette;
  • Gestione circolare9;
  • Submission of promotional material, sponsorships;
  • Regulatory and promotional activities related to parapharmaceutical products and medical devices;

Product Information (PIL, LABEL, SmPC, FIT Card)

  • Texts Translations, preparations, maintenance, modifications and updates;
  • QRD adjustments;
  • RUT (Readability User Test);
  • Translations from and into Italian from different languages (TUV certificate);
  • Farmastampati management;
  • Artwork review and preparation of FIT board;

OP Pharma integrates the services listed above with e-Reg

All the services

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