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.

Ideal for :
Enterprises
Startups

Structured Journey to Compliance

Built to guide every step with clarity, speed, and regulatory precision - from planning to execution.

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Setup and maintenance of AE reporting systems

Establish automated or manual workflows for capturing and reporting adverse events as per global requirements.

Adverse Event (AE) & Pharmacovigilance Management

Signal detection and benefit-risk evaluation

Analyse cumulative safety data to identify new risks and assess evolving product benefit-risk profiles. 

Adverse Event (AE) & Pharmacovigilance Management

Case intake, assessment, and regulatory submission

Process AE reports, evaluate causality, and submit cases to relevant health authorities using approved formats.

Adverse Event (AE) & Pharmacovigilance Management

Safety data reconciliation and narrative writing

Adverse Event (AE) & Pharmacovigilance Management

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 Handling System Setup & Support

Complaint logging and investigation process setup

Deploy digital or manual systems to capture complaints and trigger structured investigations.

Complaint Handling System Setup & Support

Root cause analysis support

Apply structured problem-solving tools to uncover systemic or recurring product issues.

Complaint Handling System Setup & Support

Complaint trend tracking and analytics

Monitor and report on complaint patterns to detect early warning signs and improve product performance.

Complaint Handling System Setup & Support

PSUR (Periodic Safety Update Reports)

Prepare summaries of safety data and regulatory actions for ongoing benefit-risk assessment. 

Periodic Reports Preparation

PBRER (Periodic Benefit-Risk Evaluation Reports)

Periodic Reports Preparation

PMCF Reports (for medical devices)

Generate Post-Market Clinical Follow-up reports to demonstrate continued device safety and effectiveness. 

Periodic Reports Preparation

Trend Reports (as per EU MDR)

Analyse adverse event or complaint trends to meet EU MDR surveillance requirements. 

Periodic Reports Preparation

Annual safety or vigilance reports for local authorities

Compile jurisdiction-specific reports as required for ongoing local market approvals.

Periodic Reports Preparation
No items found.

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

Capabilities Regnova Team Client’s In-House Team Independent Consultants
End-to-End Vigilance Setup Full AE systems, SOPs, submissions Partial or informal Case-level only
Global Regulatory Reporting Readiness MedWatch, EudraVigilance, PVPI ready One or two regions only Inconsistent formats
Complaint Handling Integration SOPs, RCA tools, trend tracking Incomplete linkage Often excluded
Periodic Report Expertise PSUR, PBRER, PMCF, trend reports Limited experience Market-dependent
Root Cause & Trend Analytics Structured tools (5-Whys, Ishikawa) Basic or ad-hoc Not included

Our Global Presence

United States
Thailand
Srilanka
Singapore
Malaysia
India
Indonesia
United States
Thailand
Srilanka
Singapore
Malaysia
India
Indonesia
United States
Thailand
Srilanka
Singapore
Malaysia
India
Indonesia
United States
Thailand
Srilanka
Singapore
Malaysia
India
Indonesia
United States
Thailand
Srilanka
Singapore
Malaysia
India
Indonesia
United Kingdom
Vietnam
United Arab Emirates
Russia
Taiwan
Srilanka
South Korea
Poland
Peru
Philippines
New Zealand
Nepal
Myanmar
Mongolia
Mexico
Maldives
Laos
Japan
Australia
China
Chile
Brazil
Cambodia
Brunei
Canada
Bangladesh
United Kingdom
Vietnam
United Arab Emirates
Russia
Taiwan
Srilanka
South Korea
Poland
Peru
Philippines
New Zealand
Nepal
Myanmar
Mongolia
Mexico
Maldives
Laos
Japan
Australia
China
Chile
Brazil
Cambodia
Brunei
Canada
Bangladesh

Proven Impact. Precision in Execution

Accelerated product readiness through compliance-aligned development, technical validation, and seamless transition from lab to launch.

100%
AERs closed within regulatory timelines (15 days or less)
5
Product complaints resolved across packaging, labeling, taste, and color
30 Days
Average complaint closure time (vs. 60-day industry average)

Launch right with Regnova

From compliance to commercial success we’ve got you covered.

Frequently Asked Questions

How scalable is the program for companies with growing product portfolios?

Our modular model supports scale - from single product surveillance to portfolio-wide coverage, with options to expand to new geographies.

Do you help prepare periodic reports if source data is scattered across systems?

Yes, we reconcile safety data from multiple sources and consolidate it into regulator-ready PSURs, PBRERs, or PMCFs with narrative support.

What level of customization do you offer for complaint handling systems?

We build tailored SOPs, integrate root cause tools (e.g., Ishikawa, 5-Why), and align the process to your product class and geography.

How do you support regulatory submissions for adverse events across regions?

We handle case intake, evaluation, and submissions to systems like MedWatch, EudraVigilance, and PVPI -ensuring format and timeline compliance.

Can you manage both pharmacovigilance and medical device vigilance under one PMS model?

Yes ,our program is structured to support both pharma (AE case management, PBRERs) and devices (PMCF, trend reports) through a unified framework.

Stay Compliant Beyond Launch

Ensure ongoing safety, regulatory alignment, and risk control through structured surveillance and lifecycle compliance support.