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 >