Clear the path to market with faster approvals, smarter execution, and built-in regulatory foresight.
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
ComplianceBuilt to guide every step with clarity, speed, and regulatory precision - from planning to execution.
In-depth review of formulation, ingredient acceptability, and dossier availability to evaluate regulatory readiness.
Strategic analysis to identify accessible markets for the product based on category fit, regulatory pathways, and compliance barriers.
Identification of optimal submission pathways based on product type and target market.
Detailed checklist of regulatory documents, technical files, and data required and gap analysis per region and product classification.
Market-by-market estimation of approval timelines and milestone planning to align internal launch schedules and supply readiness.
For digitally regulated markets (e.g., US, EU, GCC)
For ASEAN markets following harmonized technical standards
For regions accepting non-eCTD digital structures
For markets with unique formats, administrative structures, or local language needs
Preparation and filing of product-specific regulatory applications
End-to-end management of Drug Master Files and Chemistry, Manufacturing & Controls sections
Handling of regulatory queries, clarification requests, and pre/post-submission communication
Acting as the local MAH in eligible markets to enable compliant registration
Leveraging trusted local partners to hold MAH with oversight from Regnova
Serving as the official local representative for regulatory interactions
Services
Get regulatory-aligned manufacturing support with vetted CMOs for scalable, compliant product supply
Facilitate strategic discussions with Health Authorities to clarify pathways and accelerate approvals.
Access early insights on market dynamics, competitor positioning, and regulatory barriers before launch.
USP
Flexibility
Structured Execution Model
Structured Execution Model
Our Global
PresenceProven Impact.
Precision in ExecutionAccelerated product approvals, reduced submission cycles, and multi-market access - delivered through structured execution and regulatory foresight.
From compliance to commercial success we’ve got you covered.
Questions
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.
Break into new markets with speed, certainty, and structure -through a program built for real-world approvals and expansion.