🇺🇦 Regulatory Affairs Services – Ukraine
REGULATORY NEXUS GLOBAL
Ukraine Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products
REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, providing regulatory affairs services for product registration in Ukraine.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic manufacturers with regulatory dossier preparation, technical documentation and regulatory submission support required for product registration and market authorization in Ukraine.
Our regulatory professionals help companies navigate Ukraine’s healthcare regulatory framework and ensure successful product registration and regulatory compliance.
Our Mission
To simplify regulatory compliance for companies exporting to Ukraine and support manufacturers in successfully registering and marketing their products through scientifically compliant regulatory documentation.
Regulatory Authority in Ukraine
Pharmaceutical regulation in Ukraine is overseen by the
State Expert Center of the Ministry of Health of Ukraine (SEC).
The authority regulates:
• Pharmaceutical product registration
• Clinical trial approvals
• Import authorization for medicines
• Pharmacovigilance and drug safety monitoring
• Quality control and regulatory compliance
• Veterinary medicinal products
REGULATORY NEXUS GLOBAL provides complete regulatory documentation and submission support for product registration in Ukraine.
Our Core Regulatory Services for Ukraine
Pharmaceutical Dossier Preparation
We prepare pharmaceutical product registration dossiers for Ukraine according to national regulatory requirements and international ICH CTD guidelines.
Our services include:
• CTD dossier preparation
• Generic drug registration documentation
• Quality / CMC documentation
• Stability study documentation
• Bioequivalence documentation
• Regulatory submission support
Our regulatory experts ensure that dossiers comply with Ukraine Ministry of Health evaluation standards.
API Documentation & Regulatory Support
For API manufacturers exporting to Ukraine, we provide:
• Drug Master File (DMF) documentation
• Active Substance Master File (ASMF) documentation
• API regulatory compliance documentation
• Import authorization support
Nutraceutical & Food Supplement Registration
REGULATORY NEXUS GLOBAL prepares regulatory documentation for nutraceuticals and food supplements exported to Ukraine, including:
• Product technical dossiers
• Ingredient regulatory compliance documentation
• Export registration documentation
• Label compliance review
Herbal & Traditional Medicine Registration
Herbal and traditional medicinal products are widely used in Eastern Europe.
We provide regulatory documentation for:
• Herbal medicine registration dossiers
• Traditional medicine regulatory documentation
• Safety and ingredient documentation
• Export registration support
Cosmetic Product Compliance for Ukraine
We provide regulatory documentation services for cosmetic and personal care products exported to Ukraine, including:
• Cosmetic Product Information File (PIF)
• Ingredient regulatory compliance documentation
• Safety assessment documentation
• Cosmetic export registration dossiers
Veterinary Product Registration
REGULATORY NEXUS GLOBAL also provides documentation services for veterinary medicines exported to Ukraine, including:
• Veterinary drug registration dossiers
• Technical regulatory documentation
• Export regulatory compliance support
Additional Regulatory Support
We also provide:
• Technical document writing
• Product development reports
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence report writing
• Regulatory gap analysis
• Regulatory strategy planning for Ukraine registration
• Export registration support
Eastern Europe Market Support
In addition to Ukraine, REGULATORY NEXUS GLOBAL supports regulatory documentation for Eastern European markets, including:
• Poland
• Romania
• Moldova
• Belarus
• Georgia
Our regulatory team ensures dossiers meet country-specific regulatory requirements and international standards.
Why Choose REGULATORY NEXUS GLOBAL for Ukraine Registration
✔ Expertise in Eastern European regulatory markets
✔ ICH-compliant dossier preparation
✔ Experience in pharmaceutical and herbal registrations
✔ Strong regulatory documentation capabilities
✔ End-to-end regulatory support
✔ Reliable scientific and regulatory solutions
About REGULATORY NEXUS GLOBAL
REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, India.
We specialize in global regulatory affairs, export documentation and product registration services for pharmaceutical, nutraceutical, herbal, veterinary and cosmetic products.