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Pharmacovigilance EU/MENA/LATAM

Pharmacovigilance EU, MENA & LATAM

More than ever, pharmacovigilance is a key issue in regulated markets. Safety and legislation are in the core of our philosophy. An experienced and fully dedicated team is always available for you and your patients in Baupharma.

  • PSMF
    • Creation
    • Review/Update
  • EU QPPV (Qualified Person for Pharmacovigilance)
  • Local QPPVs (Local Qualified Person for Pharmacovigilance)
  • Local Safety Officers
  • Drug Safety Officers
  • Literature search
    • Global
    • Local
  • Data Management
    • PV Database
    • ICSR
    • Eudravigilance: Download, conversion to XML and analysis
    • XEVMPD
    • IDMP
  • Audits
    • Inspections Support
    • Assistance in Critical Findings
    • CAPA preparation
  • Pharmacovigilance Training
  • Pharmacovigilance Intelligence

In terms of Local QPPVs (Local Qualified Person for Pharmacovigilance), Drug Safety Officers (DSO) and Named Safety Contact (NSC), we cover the following countries:

Europe:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic/Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany, including Stufenplanbeauftragter
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Malta
  • Netherlands
  • Norway
MENA:
  • Algeria
  • Bahrain
  • Djibouti
  • Egypt
  • Iran
  • Iraq
  • Israel
  • Jordan
  • Kuwait
  • Lebanon
  • Libya
  • Mauritania
  • Morocco
  • Oman
  • Qatar
  • Saudi Arabia
  • Somalia
  • Sudan
  • Tunisia
  • United Arab Emirates (UAE)
  • Yemen
LATAM:
  • Argentina
  • Bolivia
  • Brazil
  • Chile
  • Colombia
  • Costa Rica
  • Dominican Republic
  • Ecuador
  • El Salvador
  • French Guiana
  • Guadaloupe
  • Guatemal
  • Haiti
  • Honduras
  • Martinique
  • Mexico
  • Nicaragua
  • Panama
  • Paraguay
  • Peru
  • Puerto Rico
  • Uruguay
  • Venezuela

If you are interested in further information, get in contact with us at phv@baupharma.com

Medical Writing

In order to register a product or be compliant with current requirements and legislation, you need to have your documentation ready and up-to-date. Our writers, with medical and pharmaceutical background, are here to assist you:

  • Environmental Risk Assessment
  • PSMF
  • Risk Management Plan
  • Nonclinical Overview & Summary
  • Clinical Overview & Summary
  • PSURs
  • DSURs
  • SOPs
  • CAPAs preparation

If you are interested in further information, get in contact with us at phv@baupharma.com