Post Market Surveillance Program
Sustain regulatory confidence post-launch with structured vigilance, reporting, and global compliance continuity.
Overview
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 Compliance
Built to guide every step with clarity, speed, and regulatory precision - from planning to execution.
Setup and maintenance of AE reporting systems
Establish automated or manual workflows for capturing and reporting adverse events as per global requirements.
Signal detection and benefit-risk evaluation
Analyse cumulative safety data to identify new risks and assess evolving product benefit-risk profiles.
Case intake, assessment, and regulatory submission
Process AE reports, evaluate causality, and submit cases to relevant health authorities using approved formats.
Safety data reconciliation and narrative writing
Design and implementation of Complaint Handling SOPsDesign and implementation of Complaint Handling SOPs
Create compliant, product-specific procedures for logging, reviewing, and closing complaints.
Complaint logging and investigation process setup
Deploy digital or manual systems to capture complaints and trigger structured investigations.
Root cause analysis support
Apply structured problem-solving tools to uncover systemic or recurring product issues.
Complaint trend tracking and analytics
Monitor and report on complaint patterns to detect early warning signs and improve product performance.
PSUR (Periodic Safety Update Reports)
Prepare summaries of safety data and regulatory actions for ongoing benefit-risk assessment.
PBRER (Periodic Benefit-Risk Evaluation Reports)
PMCF Reports (for medical devices)
Generate Post-Market Clinical Follow-up reports to demonstrate continued device safety and effectiveness.
Trend Reports (as per EU MDR)
Analyse adverse event or complaint trends to meet EU MDR surveillance requirements.
Annual safety or vigilance reports for local authorities
Compile jurisdiction-specific reports as required for ongoing local market approvals.
Add on Services
Product Recall Support
End-to-end coordination for compliant, timely product recalls across markets from risk assessment to regulatory reporting
Advertising/Promotional Compliance
Review and validate promotional content to ensure regulatory alignment and avoid post-market enforcement risks
Our USP
Engagement Flexibility
Project / Scope-Based Model
Structured Execution Model
- One-time PMS tasks (e.g., PSUR, complaint audit)
- Fixed scope and clear deliverables
- Short-term or periodic engagement
- Ideal for brands with limited post-market load
Retainer-Based Model
Continuous Support Model
- Continuous AE handling and report submissions
- Real-time monitoring and data reconciliation
- Monthly or quarterly billing
- Suited for ongoing, multi-market compliance
Our Global Presence
Proven Impact. Precision in Execution
Accelerated product readiness through compliance-aligned development, technical validation, and seamless transition from lab to launch.
Launch right with Regnova
From compliance to commercial success we’ve got you covered.
Frequently Asked 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.
Yes ,we assess packaging feasibility for compliance and stability, and we review claims for regulatory alignment and substantiation.
No problem. The program is modular - you can engage for pilot batch execution or any other defined phase independently.
Absolutely. Through our partner lab network, we coordinate analytical, stability, and safety testing as part of the launch preparation process.
Yes, we conduct region-specific ingredient reviews to assess acceptability, regulatory status, and associated risks across target geographies.
This program is designed to support both early-stage concept development and post-formulation refinement. The earlier you engage, the more aligned your product will be with regulatory and market expectations.
Yes - the program is fully modular. You can choose specific steps based on your internal readiness and regulatory needs.
Timelines vary by product type and market, but most projects are completed within 6-9 months, which is 15-20% faster than standard industry timelines.
It’s built for both. Whether you're entering a market for the first time or expanding your footprint, the program adapts to your regulatory maturity and market goals.
Regnova or its channel partners can act as MAH or legal representatives, ensuring full compliance without needing a local entity.
Unlike traditional advisory models, this program offers end-to-end execution -from feasibility assessment to dossier submission and MAH support -with built-in speed and regional alignment.
Stay Compliant Beyond Launch
Ensure ongoing safety, regulatory alignment, and risk control through structured surveillance and lifecycle compliance support.
