Post-Market Surveillance & Vigilance Support
The Importance of Post-Market Surveillance in Life Sciences
Post-market surveillance (PMS) plays a critical role in ensuring ongoing patient safety, product effectiveness, and regulatory compliance after a product reaches the market. For pharmaceutical, biotech, and medical device companies, regulatory responsibility does not end at approval it continues throughout the product lifecycle. Effective post-market surveillance enables organizations to identify safety signals early, respond to adverse events, and maintain trust with regulators and patients. Failure to do so can result in regulatory actions, recalls, reputational damage, and financial loss.
Regulatory Expectations for Post-Market Vigilance
Global regulators expect robust and proactive post-market vigilance programs. Key regulatory frameworks include:
FDA post-market surveillance requirements
EU MDR and IVDR vigilance obligations
ICH E2 guidelines for pharmacovigilance
ISO 13485 post-market monitoring requirements
Organizations must demonstrate clear processes for adverse event reporting, complaint handling, trending, and corrective actions—all supported by audit-ready documentation.
Our Approach to Post-Market Surveillance & Vigilance
BioNetwork Consulting delivers a risk-based, scalable approach to post-market surveillance tailored to your product type and regulatory landscape. Our approach includes:
PMS Program Assessment: Evaluate existing systems and gaps
Safety Data Collection: Establish structured processes for data intake
Signal Detection & Trending: Identify emerging safety risks
Regulatory Reporting: Ensure timely and accurate submissions
CAPA Management: Implement corrective and preventive actions
Continuous Improvement: Optimize systems as products and regulations evolve
Key Benefits of Partnering with BioNetwork Consulting
Regulatory Confidence: Meet FDA, EMA, and global vigilance expectations
Patient Safety Assurance: Proactively identify and mitigate risks
Operational Efficiency: Streamlined surveillance workflows
Audit Readiness: Inspection-ready documentation and reporting
Scalable Support: Flexible solutions for startups through global enterprises
Our consultants bring hands-on experience across drugs, devices, combination products, and digital health solutions.
Post-Market Surveillance Services We Offer
Our comprehensive post-market surveillance and vigilance services include:
Adverse event intake and case processing
Complaint handling system setup and optimization
Safety signal detection and trending analysis
Regulatory reporting (FDA, EMA, global authorities)
Post-market clinical follow-up (PMCF) support
Risk management file updates
CAPA development and execution
Vendor and safety partner oversight
Ensuring Audit Readiness and Continuous Compliance
BioNetwork Consulting ensures your post-market surveillance program is inspection-ready at all times. We support:
FDA inspections and EU MDR audits
Documentation reviews and remediation
Data integrity and traceability assessments
Ongoing monitoring for regulatory changes
Our proactive approach minimizes compliance risk and supports long-term product success.