SERVICES →

Pharmacovigilance Programs

Comprehensive post-market pharmacovigilance activities support

SERVICES →

Pharmacovigilance Programs

Comprehensive post-market pharmacovigilance activities support

For over 20 years, we have providing consultation on drug and natural health product pharmacovigilance to help companies stay current with regulatory demands and expectations, improve internal processes and ensure compliance for collection, detection, assessment, monitoring and prevention of adverse reactions.

Services and Solutions

There is an obligation for marketing authorization holders to maintain a pharmacovigilance program. This means if your company imports and/or distributes DIN or NPN products your Quality Control Department must be able to receive, assess and where applicable report adverse events to Vigilance Canada within a prescribed time period depending on the nature of the event. With a full understanding of current and upcoming pharmacovigilance requirements, MCS offers the following services quickly and cost-effectively.

  • Preparation / Review of Standard Operating Procedures (SOPs)
  • Review and Preparation of Quality Agreements
  • Complaint Assessment and Review for Reporting Criteria
  • Reporting Adverse Events
  • Complaint Handling (Domestic & Foreign)
  • Contract Medical Evaluation for Topicals
  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefits Risk Evaluation Reports (PBRERS)
  • Annual Summary Reports (ASRs)
  • Issue-Related Summary Reports (IRSRs)
  • Literature Search
  • Line Listing & Summary Tabulation
  • MedDRA & SOC Classifications
  • Evaluation of Safety Updates
  • Pharmacovigilance Inspections (Hosting & Support)
  • GVP Gap Analysis
  • Third Party Audits
  • Remediation Plans
  • GVP Self-Inspections
  • Gap Analysis of Pharmacovigilance Processes
  • Complete Management of Pharmacovigilance Programs
  • Computer System Validation
  • Self Inspection of Third Party Call Centers
  • Good Pharmacovigilance Practices (GVP)
  • Post Market Reporting Compliance
  • Complaint Handling

Contact Us