VI.REL Pharma

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Address:

Piazza Vittorio Veneto 12
Torino
10123
Italy

Email: pbiffignandi@virelpharma.it
Website: https://www.virelpharma.it/
Phone: +39-011-00148.38

Skills and Services:

VI.REL Consulting in Medical Writing offers expert, specialized support across a broad spectrum of pharmaceutical services throughout all stages of a product's lifecycle, delivering our clients high-quality scientific documentation. Through synergies with a team of experts (pharmacologists, clinicians, and pharmacists) we can support our clients in the following activities: Regulatory writing of European CTD dossiers: Modules I and II (nonclinical and clinical overviews and summaries), assistance in completing Modules 4 and 5. Drafting of pharmacological reports on environmental impact – Environmental Risk Assessment (ERA). In addition, VI.REL can manage all writing activities in pharmacovigilance.

Expertise:

VI.REL Pharma was founded in 1997 as a specialized consulting firm in the field of drug R&D.
Today, the VI.REL group consists of a team of international professionals with multidisciplinary experience, combining scientific, medical and regulatory knowledge.

We were involved in more than 250 regulatory procedures, from centralised to national, with an impressive score of success. Membership of our members to reputed organisations, such as EMWA, DIA, PIPA, and TOPRA, insures our continuing education and update. VI.REL Pharma is an ISO-9001 certified company.

Other Information:

Since 2008, VI.REL has been acting as a Service Provider capable of meeting the different needs of Clients in pharmacovigilance: from comprehensive management of pharmacovigilance activities to spot activities.

Below is a list of the services we offer to our clients:

  • European Qualified Person for Pharmacovigilance (QPPV) and Local Contact Person (LCP) in Italy.
  • Pharmacovigilance Physician
  • Support in Pharmacovigilance activities, including the drafting and maintenance of PSMFs and related SOPs
  • Case management and follow-up
  • Indexed and non-indexed literature search
  • Signal management and Signal Detection Report writing.
  • Management of the database “Art 57”
  • Pharmacovigilance Training
  • Safety Database Management,
  • Drafting of risk-management plan (RMP), Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR)
  • Pharmacovigilance Audits, Due Diligence