Sustain regulatory confidence post-launch with structured vigilance, reporting, and global compliance continuity.
Post-Market Surveillance (PMS) refers to the systematic process of monitoring the safety, quality, performance, and regulatory compliance of a product after it has been launched in the market. It is a critical element of the product lifecycle that ensures continued safety and effectiveness under global regulatory conditions.
Structured Journey to
ComplianceBuilt to guide every step with clarity, speed, and regulatory precision - from planning to execution.
Establish automated or manual workflows for capturing and reporting adverse events as per global requirements.
Analyse cumulative safety data to identify new risks and assess evolving product benefit-risk profiles.
Process AE reports, evaluate causality, and submit cases to relevant health authorities using approved formats.
Create compliant, product-specific procedures for logging, reviewing, and closing complaints.
Deploy digital or manual systems to capture complaints and trigger structured investigations.
Apply structured problem-solving tools to uncover systemic or recurring product issues.
Monitor and report on complaint patterns to detect early warning signs and improve product performance.
Prepare summaries of safety data and regulatory actions for ongoing benefit-risk assessment.
Generate Post-Market Clinical Follow-up reports to demonstrate continued device safety and effectiveness.
Analyse adverse event or complaint trends to meet EU MDR surveillance requirements.
Compile jurisdiction-specific reports as required for ongoing local market approvals.
Services
End-to-end coordination for compliant, timely product recalls across markets from risk assessment to regulatory reporting
Review and validate promotional content to ensure regulatory alignment and avoid post-market enforcement risks
USP
Flexibility
Structured Execution Model
Continuous Support Model
Our Global
PresenceProven Impact.
Precision in ExecutionAccelerated product readiness through compliance-aligned development, technical validation, and seamless transition from lab to launch.
From compliance to commercial success we’ve got you covered.
Questions
Our modular model supports scale - from single product surveillance to portfolio-wide coverage, with options to expand to new geographies.
Yes, we reconcile safety data from multiple sources and consolidate it into regulator-ready PSURs, PBRERs, or PMCFs with narrative support.
We build tailored SOPs, integrate root cause tools (e.g., Ishikawa, 5-Why), and align the process to your product class and geography.
We handle case intake, evaluation, and submissions to systems like MedWatch, EudraVigilance, and PVPI -ensuring format and timeline compliance.
Yes ,our program is structured to support both pharma (AE case management, PBRERs) and devices (PMCF, trend reports) through a unified framework.
Ensure ongoing safety, regulatory alignment, and risk control through structured surveillance and lifecycle compliance support.