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.

Ideal for :
Startups
Enterprises
Emerging brands

Structured Journey to Compliance

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

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Product Feasibility

In-depth review of formulation, ingredient acceptability, and dossier availability to evaluate regulatory readiness.

Feasibility Scan

Market Feasibility

Strategic analysis to identify accessible markets for the product based on category fit, regulatory pathways, and compliance barriers.

Feasibility Scan

Regulatory Route Mapping

Identification of optimal submission pathways based on product type and target market. 

Regulatory Strategy

Technical & Documentation Requirements & Review Planning

Detailed checklist of regulatory documents, technical files, and data required and gap analysis per region and product classification.

Regulatory Strategy

Approval Timeline Forecasting

Market-by-market estimation of approval timelines and milestone planning to align internal launch schedules and supply readiness.

Regulatory Strategy

eCTD Compilation

For digitally regulated markets (e.g., US, EU, GCC)

Dossier Builder

ACTD Compilatio

For ASEAN markets following harmonized technical standards 

Dossier Builder

NeeS Format Compilation

For regions accepting non-eCTD digital structures 

Dossier Builder

Country-Specific Dossier Development

For markets with unique formats, administrative structures, or local language needs 

Dossier Builder

NDA, ANDA, and Medical Device Submissions

Preparation and filing of product-specific regulatory applications 

Dossier Submission

DMF Filing and CMC Documentation

End-to-end management of Drug Master Files and Chemistry, Manufacturing & Controls sections 

Dossier Submission

Health Authority Interactions

Handling of regulatory queries, clarification requests, and pre/post-submission communication 

Dossier Submission

MAH Sponsorship via Regnova

Acting as the local MAH in eligible markets to enable compliant registration 

MAH Enablement

MAH Sponsorship via Channel Partners

Leveraging trusted local partners to hold MAH with oversight from Regnova

MAH Enablement

In-Country Legal Representation

Serving as the official local representative for regulatory interactions 

MAH Enablement
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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

Capabilities Regnova Team Client’s In-House Team Independent Consultants
Speed to Market 6–9 months average 12–18 months 9–12 months
Regional Regulatory Knowledge US, EU & Asia covered Limited Varies by market
Execution Model End-to-end, risk-aligned Fragmented by team scope Advisory-only, not integrated
MAH Enablement Legal interface via RegNova Not available Country-dependent
Total Cost Efficiency High – due to time/resource savings Low – high FTE involvement Medium – multiple touchpoints

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 approvals, reduced submission cycles, and multi-market access - delivered through structured execution and regulatory foresight.

40%
Faster regulatory approvals achieved across APAC markets
95%
First-cycle approval success across 5 regulatory agencies
$50K+
Cost saved through early pathway mapping and compliance checks

Launch right with Regnova

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

Frequently Asked Questions

Can we engage only for specific steps, like dossier preparation or submission?

Yes - the program is fully modular. You can choose specific steps based on your internal readiness and regulatory needs.

How long does the Market Entry Acceleration Program typically take?

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.

Is this program suitable for first-time market entrants or only experienced brands?

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.

How do you help with Marketing Authorization in countries where we don't have a local office?

Regnova or its channel partners can act as MAH or legal representatives, ensuring full compliance without needing a local entity.

What makes the Market Entry Acceleration Program different from typical regulatory consulting?

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.