Product Safety (PV)

DSA offers a range of pharmacovigilance services to DSA Clients to meet adverse reaction reporting requirements for natural health products.  Each client relationship is different, and services offered can range from DSA holding all of the Canadian PV responsibility to a shared responsibility with the client or other parties.  Our services include:

• Writing SOPs to govern the Canadian pharmacovigilance program.
• Establishing safety profiles 
• Preparing agreements such as Safety Data Exchange Agreements for Canada or Pharmacovigilance Agreements
• Reporting domestic serious unexpected and unexpected adverse reactions (AR) to Health Canada
• Reporting foreign serious unexpected adverse reactions (AR) to Health Canada
• Monitoring Regulatory Authorities Sources
• Monitoring Scientific Literature
• Preparing Annual Summary Reports or Periodic Safety Update Reports (PSUR)
• Conducting Signal Detection Reviews
• Conducting PV Self-Inspections or PV Audits of other service providers.
• Qualified Healthcare Practitioners on staff to meet Canadian requirements