Your Trusted Partner for European Market Access
Entering Europe: Beyond Marketing Authorization
Entering the European market isn’t just about gaining marketing authorization — it’s about sustaining it.
For pharmaceutical companies, long-term success depends on two non-negotiables: quality and compliance. These pillars safeguard patient safety and regulatory trust. To achieve seamless entry and lasting growth, a deep understanding of both is essential.
Trusted Partnership for Sustainable Market Access
Our EU partner, acting as the Marketing Authorization Holder (MAH), has built a strong reputation for managing regulatory responsibilities with precision, consistency, and agility.
With hands-on expertise, local networks, and regional insight, we support clients across diverse jurisdictions — delivering seamless, compliant, and forward-looking regulatory solutions.
Europe: A Region of Regulatory Diversity
Europe is not a one-size-fits-all region. It represents a mosaic of regulatory environments, each with distinct authority structures, national policies, and procedural frameworks.
While many countries align with EU legislation, others maintain independent national standards in certain areas. Even where harmonization exists, implementation and interpretation vary — adding complexity for pharmaceutical companies.
We understand these nuances — not just in theory, but through practice.
Our team has successfully navigated:
Local registration procedures
Country-specific labelling and packaging requirements
National timelines and dossier expectations
Language mandates and translation best practices
We don’t just react to regulations — we anticipate, strategize, and execute with purpose.
Our Role as a Marketing Authorization Holder
Being an MAH is more than a legal formality — it’s a critical operational responsibility.
We ensure your product remains compliant with national laws, pharmacovigilance obligations, and ethical marketing practices throughout its lifecycle.
Our Integrated MAH Model Ensures:
Regulatory Compliance
Continuous monitoring of legislation and proactive implementation of updates — from pharmacovigilance reporting to maintaining ongoing authorization.
Lifecycle Management
Comprehensive support from submission to renewal and post-authorization variations — minimizing delays and maintaining uninterrupted market presence.
Regulatory Intelligence
Ongoing insight collection from authorities, forums, and industry trends — empowering you to act on information, not react to disruption.
Our MAH Service Offering
Local Representation: Acting as MAH or local regulatory representative for companies without a legal entity in the EU.
Regulatory Strategy & Planning: Advising on national requirements, costs, documentation, and timelines.
Gap Analysis & Dossier Review: Ensuring registration files meet country-specific standards before submission.
Regulatory Due Diligence: Supporting acquisitions, licensing, or divestments through comprehensive regulatory assessment.
Product Transfer Management: Managing MAH transfers and ensuring business continuity during ownership or structural changes.
We don’t engage in commercial distribution — our focus is strategic and regulatory.
We help companies establish compliant local operations, offering tailored insights into each country’s regulatory and market landscape to guide investment, resource planning, and launches.
Why Choose Us as Your MAH Partner
Trusted local and regional expertise
Proven success across complex regulatory systems
Reliable end-to-end regulatory management
Transparent communication and strategic collaboration
Seamless coordination between central and local teams
In a region defined by regulatory complexity, we bring clarity. In markets where timelines shift and standards evolve, we ensure stability. And when success depends on getting it right the first time — we’re the partner you can rely on.
Ready to expand your presence in Europe or beyond?
Let us guide you — with the insight, precision, and partnership only an experienced MAH can provide.
Registration Fees
Fresh Registration
Fee: 5,500,000 VND (~ 220 USD).
Variation Submission (MiV or MaV)
Fee: 1,200,000 VND (~ 48 USD) per variation dossier
5-Year Visa Extension
Fee: 1,500,000 VND (~ 60 USD).
Pre- Submission
Submission
Fee Payment
Post Decision
