Market Entry Acceleration Program
Clear the path to market with faster approvals, smarter execution, and built-in regulatory foresight.
Overview
Market Entry Acceleration Program helps brands understand market dynamics, navigate evolving regulatory guidelines, and build tailored regulatory strategies - enabling confident, compliant, and well-informed product launches across complex and competitive environments.
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
Add on Services
CMO
Get regulatory-aligned manufacturing support with vetted CMOs for scalable, compliant product supply
Meeting & Liaison with Authorities
Facilitate strategic discussions with Health Authorities to clarify pathways and accelerate approvals.
Pre-market Intelligence & Competitive Benchmarking
Access early insights on market dynamics, competitor positioning, and regulatory barriers before launch.
Our USP
Engagement Flexibility
Scope-Based
Defined scope, fixed deliverables
- Engage by specific steps or services
- Fixed scope, timeline, and deliverables
- No retainer or long-term lock-in
- Flexible for single or multi-market launches
Embedded Model
Integrated workflows, shared execution
- Deep alignment with internal teams
- Joint decision-making and governance
- Shared tools and collaboration systems
- Ideal for multi-country scale-up
Our Global Presence
Proven Impact. Precision in Execution
Accelerated product approvals, reduced submission cycles, and multi-market access - delivered through structured execution and regulatory foresight.
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.
Make Regulatory Execution Your Growth Advantage
Break into new markets with speed, certainty, and structure -through a program built for real-world approvals and expansion.
