Regulatory and Pharmacovigilance Services
Founded in 1999 as a consultancy and service company in the pharmaceutical field, it counts on expert professionals in the ever-changing and challenging global regulatory and safety requirements for clinical and post-marketing medicinal products.
The mission is to provide consulting services in the areas of Regulatory Affairs, Pharmacovigilance, Developments and Registration of Medicinal Products, Medical Devices and Food Supplements.
With the highly qualified staff, Proge Medica offers an all-around consultancy dealing with client company’s business and technical operations, with Italian and European Competent Authorities as well as Academic Institutions.
- Strategic consultancy for regulatory registration and maintenance of medicinal product authorization;
- Consultancy regarding national and international legislation;
- Submission of regulatory documents for MA applications with National, Mutual Recognition and Decentralized procedures;
- Management of regulatory procedures for the submission of scientific and technical variations and renewals of MA;
- Updating of old dossiers in CTD format;
- Due diligence of registration dossier;
- Technical and scientific consultancy for the achievement of GMP and GLP Certificates;
- Local requirements compliance for medicinal products and medical devices advertising;
- Medical Sales Representatives management;
- Medical Devices: ISO 13485:2012 certification support and Technical File Management;
- Food supplements: claims and regulatory advice;
- Advisory Board organization;
- Custom training for third parties.
- Support on Pharmacovigilance System set up;
- Preparation and maintenance of the Pharmacovigilance System Master File (PSMF);
- EU QPPV and Deputy provision;
- Collection of all cases of suspected adverse reactions (ADRs) from different sources with the related activities: local and worldwide literature monitoring, daily access to Pharmacovigilance National Network (RNF);
- Processing of all cases of suspected adverse reactions (ADRs) reported directly to the Company, received from the Authorities or published in the international and local scientific literature;
- Provision of a validated database for cases processing through the activities of "data entry", "quality check" and "medical evaluation" and for producing different types of documents (es. CIOMS forms, line listings, summary tabulations);
- Reporting of cases of suspected adverse reactions (ADRs) to the Competent Authorities, when required;
- Preparation and submission of Periodic Safety Update Reports (PSURs);
- Preparation of Addendum to the Clinical Overview (AdCO) contextually with Renewal procedures;
- Preparation of Risk Management Plans (RMPs);
- Signal management;
- Management of Eudravigilance database: registration processes and provision of Users, data entry and maintenance of product details in XEVMPD, ICSR submission;
- Preparation and review of Safety Data Exchange Agreements (SDEA) with contractual Partners.
Pharmabiotic Research Institute member
S.I.A.R (Italian Regulatory Affairs Society)
A.F.I. (Italian Pharmaceutical Professionals Association)
Scientific Committee at the Executive Master
“Pharmaceutical and Biotechnology Regulatory Affairs and Market Access” (University of Novara)
Collaboration as speakers with several executive master in Regulatory Affairs (at University of Novara, Milano, Pavia).