🇬🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Georgia

REGULATORY NEXUS GLOBAL

Georgia 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 Georgia.

We support pharmaceutical, nutraceutical, herbal, veterinary and cosmetic manufacturers with regulatory dossier preparation, technical documentation and regulatory submission support required for market authorization in Georgia.

Our regulatory professionals assist companies in navigating Georgia’s healthcare regulatory system and ensure efficient product registration and regulatory compliance.

Our Mission

To simplify regulatory compliance for companies exporting to Georgia and help manufacturers successfully register and market their products through scientifically compliant regulatory documentation.

Regulatory Authority in Georgia

Pharmaceutical and healthcare product regulation in Georgia is managed by the

State Regulation Agency for Medical Activities (SRAMA) under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs.

The authority regulates:

• Pharmaceutical product registration
• Import authorization for medicines
• Medical product supervision
• Pharmacovigilance activities
• Quality control of medicinal products

Georgia follows a simplified regulatory procedure for medicines registered in recognized international regulatory authorities, which can facilitate faster market entry.

REGULATORY NEXUS GLOBAL provides complete regulatory documentation and submission support for product registration in Georgia.

Our Core Regulatory Services for Georgia

Pharmaceutical Dossier Preparation

We prepare pharmaceutical product registration dossiers for Georgia in accordance with international ICH guidelines and Georgia regulatory requirements.

Our services include:

• CTD dossier preparation
• Generic drug registration documentation
• Quality / CMC documentation
• Stability study documentation
• Bioequivalence documentation (if required)
• Regulatory submission support

Our regulatory experts ensure that dossiers comply with Georgia regulatory evaluation standards.

API Documentation & Regulatory Support

For API manufacturers exporting to Georgia, we provide:

• Drug Master File (DMF) documentation
• API technical documentation
• Regulatory compliance documentation
• Import authorization support

Nutraceutical & Food Supplement Registration

REGULATORY NEXUS GLOBAL prepares regulatory documentation for nutraceuticals and food supplements exported to Georgia, including:

• Product technical dossiers
• Ingredient regulatory compliance documentation
• Export registration documentation
• Label compliance review

Herbal & Traditional Medicine Registration

We prepare regulatory documentation for herbal and traditional medicinal products, including:

• Herbal medicine registration dossiers
• Traditional medicine regulatory documentation
• Safety and ingredient documentation
• Export registration support

Cosmetic Product Compliance for Georgia

We provide regulatory documentation services for cosmetic and personal care products exported to Georgia, including:

• Cosmetic Product Information File (PIF)
• Ingredient compliance documentation
• Safety assessment documentation
• Cosmetic regulatory documentation

Veterinary Product Registration

REGULATORY NEXUS GLOBAL also provides regulatory documentation for veterinary medicinal products exported to Georgia, 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 Georgia market entry
• Export registration support

Caucasus & CIS Market Support

In addition to Georgia, REGULATORY NEXUS GLOBAL supports regulatory documentation for Caucasus and CIS markets, including:

• Armenia
• Azerbaijan
• Kazakhstan
• Uzbekistan
• Kyrgyzstan

Our regulatory team ensures dossiers meet country-specific regulatory requirements and international standards.

Why Choose REGULATORY NEXUS GLOBAL for Georgia Registration

✔ Expertise in CIS and Caucasus 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.