🇭🇺 Regulatory Affairs Services in Hungary

REGULATORY NEXUS GLOBAL

Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products in Hungary

REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, providing professional regulatory affairs services for pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies seeking product registration in Hungary and the European Union.

Hungary is a member of the European Union, and therefore pharmaceutical and healthcare product registrations must comply with European regulatory frameworks, including EU-CTD dossier requirements.

REGULATORY NEXUS GLOBAL supports companies in preparing EU-compliant regulatory dossiers, CTD documentation, and technical regulatory files required for successful product registration in Hungary and other EU member states.

Regulatory Authority in Hungary

Medicinal products and healthcare products in Hungary are regulated by the National Institute of Pharmacy and Nutrition (OGYÉI).

Product approvals must comply with the regulatory framework of the European Medicines Agency (EMA) and European pharmaceutical legislation.

REGULATORY NEXUS GLOBAL assists companies in preparing EU-compliant regulatory dossiers aligned with EMA and Hungarian regulatory requirements.

Our Mission

Our mission is to simplify regulatory compliance for the Hungarian and European pharmaceutical markets and support companies in successfully registering and marketing pharmaceutical, nutraceutical, herbal and cosmetic products in Hungary and the European Union.

Core Regulatory Services for Hungary

EU-CTD Dossier Preparation

For pharmaceutical product registration in Hungary, dossiers must comply with the European Union Common Technical Document (EU-CTD) format.

Our EU-CTD dossier preparation services include:

• Module 1 – Regional Administrative Information (EU specific)
• Module 2 – Quality Overall Summary (QOS) and Expert Reports
• Module 3 – Quality / CMC Documentation
• Module 4 – Non-Clinical Study Reports
• Module 5 – Clinical Study Reports / Bioequivalence Documentation

All documentation is prepared according to ICH, EMA and EU regulatory requirements.

EU Regulatory Submission Pathways

Pharmaceutical products in Hungary may be registered through several EU regulatory pathways:

• Centralized Procedure (CP) via European Medicines Agency
• Decentralized Procedure (DCP) for multiple EU countries
• Mutual Recognition Procedure (MRP)
• National Procedure in Hungary

REGULATORY NEXUS GLOBAL provides regulatory strategy planning and dossier preparation for all EU registration pathways.

Regulatory Services for Multiple Product Categories

Pharmaceutical Products

• Generic drug EU-CTD dossiers
• API documentation and Drug Master File (DMF) support
• Bioequivalence documentation
• CMC technical documentation
• Stability study documentation
• EU regulatory submission documentation

Nutraceuticals & Food Supplements

Nutraceuticals in Hungary must comply with European food supplement regulations and national requirements.

Our services include:

• Nutraceutical regulatory documentation
• Ingredient compliance verification
• Technical product documentation
• Export regulatory documentation

Herbal & Traditional Herbal Products

Herbal medicines in the EU must comply with guidelines of the European Medicines Agency, including the Traditional Herbal Medicinal Products Directive.

Our services include:

• Herbal medicinal product dossiers
• Botanical ingredient documentation
• Traditional herbal product regulatory documentation

Cosmetics & Cosmeceuticals

Cosmetics marketed in Hungary must comply with EU Cosmetic Regulation (EC) No. 1223/2009.

Our services include:

• Cosmetic Product Information File (PIF)
• Cosmetic Safety Assessment documentation
• EU cosmetic regulatory compliance documentation
• Ingredient regulatory compliance

Veterinary Products

• Veterinary medicinal product dossiers
• Veterinary regulatory documentation
• EU regulatory compliance documentation

Additional Regulatory Support

REGULATORY NEXUS GLOBAL also provides:

• Technical document writing
• Product development reports
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for EU markets

EU Market Support

Through Hungary, companies can access the entire European pharmaceutical market.

REGULATORY NEXUS GLOBAL supports regulatory documentation for EU market entry, including:

• Hungary
• Germany
• France
• Italy
• Spain
• Poland
• Netherlands
• Romania
• Bulgaria
• Czech Republic

Why Choose REGULATORY NEXUS GLOBAL

✔ Experienced regulatory affairs professionals
✔ Expertise in EU-CTD dossier preparation
✔ Compliance with EMA and EU regulatory frameworks
✔ Support for pharmaceuticals, nutraceuticals, herbal and cosmetics
✔ Scientific and regulatory documentation expertise
✔ End-to-end regulatory solutions for EU markets

About Zoesoe Exports Pvt Ltd

REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, a company engaged in global export consultancy, regulatory affairs services and contract manufacturing coordination for pharmaceutical, herbal, nutraceutical and cosmetic products.

Through its regulatory division, the company provides professional regulatory documentation and international product registration support for Hungary, the European Union and global regulated markets.