Pharmacovigilance Programs

Post-market pharmacovigilance is essential for not only new products but also for well-established drugs. For over 20 years, we have been providing post-market pharmacovigilance support for drug and natural health products to ensure companies stay current with regulatory compliance for post-market surveillance for the collection, detection, assessment, monitoring and prevention of adverse drug 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.

We offer the following post-market pharmacovigilance support services:

Documentation

  • 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)

Post-Market Compliance

  • Annual Summary Reports (ASRs)
  • Issue-Related Summary Reports (IRSRs)
  • Literature Search
  • Line Listing & Summary Tabulation
  • MedDRA & SOC Classifications
  • Evaluation of Safety Updates

Audits

  • 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

Training Programs

  • Good Pharmacovigilance Practices (GVP)
  • Post Market Reporting Compliance
  • Complaint Handling

MCS Associates provides pharmaceutical regulatory submissions services. Learn more >

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