Market Entry Acceleration Program

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.