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;

Contact us to request information on this Service