Post Market Surveillance Program
Ensure ongoing product safety, regulatory compliance, and market continuity with structured, post-launch vigilance and reporting.
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.
Product Feasibility
In-depth review of formulation, ingredient acceptability, and dossier availability to evaluate regulatory readiness.
Market Feasibility
Strategic analysis to identify accessible markets for the product based on category fit, regulatory pathways, and compliance barriers.
Regulatory Route Mapping
Identification of optimal submission pathways based on product type and target market.
Technical & Documentation Requirements & Review Planning
Detailed checklist of regulatory documents, technical files, and data required and gap analysis per region and product classification.
Approval Timeline Forecasting
Market-by-market estimation of approval timelines and milestone planning to align internal launch schedules and supply readiness.
eCTD Compilation
For digitally regulated markets (e.g., US, EU, GCC)
ACTD Compilatio
For ASEAN markets following harmonized technical standards
NeeS Format Compilation
For regions accepting non-eCTD digital structures
Country-Specific Dossier Development
For markets with unique formats, administrative structures, or local language needs
NDA, ANDA, and Medical Device Submissions
Preparation and filing of product-specific regulatory applications
DMF Filing and CMC Documentation
End-to-end management of Drug Master Files and Chemistry, Manufacturing & Controls sections
Health Authority Interactions
Handling of regulatory queries, clarification requests, and pre/post-submission communication
MAH Sponsorship via Regnova
Acting as the local MAH in eligible markets to enable compliant registration
MAH Sponsorship via Channel Partners
Leveraging trusted local partners to hold MAH with oversight from Regnova
In-Country Legal Representation
Serving as the official local representative for regulatory interactions
Market & Regulatory Assessment
Analyse target market trends, applicable regulatory classifications, and category-specific challenges.
Ingredient Feasibility Review
Evaluate ingredient acceptability, restrictions, and pre-approval status based on regional regulations.
Compatibility Evaluation of Active & Inactive Ingredients
Assess chemical, functional, and regulatory compatibility between components in the intended formulation.
Pre-Formulation Studies
Conduct trials to determine stability, solubility, and potential interactions of selected ingredients.
Finalization of Paper BOM
Establish the complete technical formulation, listing all components with defined specifications.
Pre-Formulation Studies
Prepare small-scale batches to validate formulation performance and process parameters.
Physio-Chemical Property Testing
Assess key properties such as pH, viscosity, dispersion, and appearance for initial quality benchmarks.
Pilot Batch Manufacturing
Execute limited-scale production runs to simulate commercial manufacturing conditions and process scalability.
Analytical & Stability Testing
Conduct validated analytical testing and ICH-compliant stability studies to establish product shelf life.
Safety & Efficacy Review
Evaluate the safety and performance profile through clinical data review or documented claims substantiation.
Manufacturing Feasibility Assessment
Ensure formulation and process compatibility with identified CDMOs or manufacturing partners.
Packaging Feasibility Evaluation
Assess packaging formats for compatibility, stability, regulatory compliance, and cost efficiency.
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.
Stay Compliant Beyond Launch
Ensure ongoing safety, regulatory alignment, and risk control through structured surveillance and lifecycle compliance support.
