Pharmacovigilance Outsourcing

  • Complete solution for small and medium sized companies
  • Includes Data Management, Signal Management, Risk Management, PV database, PSMF, QPPV, local QP, literature search (local and global), SOPs, audits, inspection support, and training
  • Respected EU-QPPVs with experienced teams
  • Regularly audited and inspected provider
  • Our team consists of experienced medical doctors and pharmacists, people from within the industry, academia and regulatory agencies including EMA

Case Management

  • Hosted fully E2B compliant and validated PV database
  • EudraVigilance and FDA electronic submissions, national submissions in the EU
  • Reconciliation and data migration services

Signal Management

  • Signal detection and signal analysis of your safety data by an experienced multidisciplinary team
  • Signal validation and evaluation reports, advice and assistance in data analysis
  • Communication with regulatory agencies regarding emerging safety issues

Risk Management Plan (EU-RMP)

  • Pre-submission development for new applications, including Advanced Therapies
  • Cost-effective EU-RMPs for generics
  • Global Risk Management solutions