Regulatory and Pharmacovigilance Services

Proge Medica

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.

Regulatory
Affairs

MEDICINAL PRODUCTS

  • 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.

MEDICAL DEVICES

  • Compliance with certification requirements;
  • Drawing up and maintenance of the Technical File;
  • Contacts with Notified Bodies and support to obtain the CE mark.

FOOD SUPPLEMENTS

  • 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.

Pharmacovigilance

  • 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).

Pharmacovigilance
Quality Assurance

  • 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).

Membership
and Affiliation

  • 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).

Proge Medica is a corporate spin off of Proge Farm, a pharmaceutical company focused on research, development, manufacturing and licensing out of products based on its patented probiotic strains.

Contacts

Largo Donegani 4/A — 28100 Novara — Italy — Tel. +39 0321 69 30 11 — Fax +39 0321 69 30 50