Regulatory and Pharmacovigilance Services
Proge Medica is a consulting Company that, over the years, has acquired a solid competence and high professionality in the pharmaceutical field, focusing its resources first on Regulatory Affairs and later on in the Pharmacovigilance field.
Its mission is to provide a wide range of services with high quality standard through skilled and qualified staff satisfying the Customers’ individual needs.
- Strategic and technical support for MA granting and maintenance (variations, extension lines, renewal applications etc.);
- Due Diligence and Gap Analysis of registration dossiers;
- Regulatory support to obtain and maintain of GLP and GMP authorization.
- Compliance with certification requirements;
- Drawing up and maintenance of the Technical File;
- Contacts with Notified Bodies and support to obtain the CE mark.
- Compliance of product information and claims with the legislation;
- Management of the notification procedure to the Italian Health Authority;
- Regulatory Support to obtain food supplements claims.
Daily update on national and European regulatory issues.
Simple or Special Prosecutor Service at Italian Competent Authorities.
- QPPV and QPPV’s Deputy availability (24/7);
- Management of the Pharmacovigilance System Master File (PSMF);
- Monitoring of local and international medical and scientific literature;
- Handling of Individual Case Safety Reports (ICSRs) through a validated and back-upped database;
- Management of Safety Data Exchange Agreements (SDEAs);
- Signal Detection activities;
- Management of Periodic Safety Update Reports (PSURs);
- Management of Risk Management Plans (RMPs);
- Drawing up of the Addendum to the Clinical Overview (AdCO);
- Management of EudraVigilance (including the Extended EudraVigilance Medicinal Product Dictionary - XEVMPD).
- Availability of a Pharmacovigilange Quality Assurance Manager (RQA);
- Drawing up and updating of Standard Operating Procedures (SOPs) and Working Instructions (WIs);
- Audit to Customers' Pharmacovigilance System;
- Drawing up and maintenance of Audit Plans applied to Pharmacovigilance (strategic, tactical and operational levels).
- Pharmabiotic Research Institute;
- S.I.A.R. (Italian Regulatory Affairs Society);
- A.F.I. (Italian Pharmaceutical Professionals Association);
- Scientific Committee at the Second Level Post Graduate Master in “Pharmaceutical and Biotechnology Regulatory Affairs and Market Access” (University of Piemonte Orientale – Novara).