🇺🇸 Regulatory Affairs Services – United States
REGULATORY NEXUS GLOBAL
United States 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 and compliance in the United States.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic manufacturers with regulatory documentation, dossier preparation, FDA compliance support and regulatory strategy for entering the US market.
Our regulatory professionals help companies navigate complex US regulatory requirements and ensure successful product approvals and compliance.
Our Mission
To simplify US regulatory compliance and help global manufacturers successfully introduce their products into the United States healthcare and consumer markets through scientifically compliant regulatory documentation.
Regulatory Authority in the United States
Pharmaceutical and healthcare product regulation in the United States is overseen by the
U.S. Food and Drug Administration (US FDA).
The FDA regulates:
• Pharmaceutical drug approvals
• Generic drug applications
• Biologics and vaccines
• Medical devices
• Nutritional supplements
• Cosmetics
• Veterinary medicines
• Food and dietary ingredients
REGULATORY NEXUS GLOBAL provides complete regulatory documentation and compliance support for FDA-regulated products.
Our Core Regulatory Services for the United States
Pharmaceutical Regulatory Submissions
We prepare regulatory submissions required for pharmaceutical product approval in the United States.
Our services include:
• ANDA (Abbreviated New Drug Application) documentation
• NDA (New Drug Application) documentation
• CTD / eCTD dossier preparation
• Quality / CMC documentation
• Stability study documentation
• Bioequivalence documentation
• FDA regulatory submission support
Our regulatory experts ensure dossiers comply with FDA regulatory requirements and ICH guidelines.
API Regulatory Support (US FDA)
For API manufacturers exporting to the US, we provide:
• Drug Master File (DMF) preparation
• API regulatory documentation
• GMP compliance documentation
• FDA regulatory submission support
Nutraceutical & Dietary Supplement Compliance
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support for dietary supplements marketed in the United States, including:
• Ingredient regulatory compliance
• New Dietary Ingredient (NDI) documentation
• Product technical dossiers
• Label compliance review
• Regulatory compliance documentation
Herbal Product Regulatory Documentation
We prepare regulatory documentation for herbal and botanical products marketed as dietary supplements in the United States.
Our services include:
• Botanical ingredient documentation
• Safety and regulatory compliance documentation
• Technical product documentation
• Export regulatory support
Cosmetic Regulatory Compliance (US)
Cosmetic products marketed in the US must comply with FDA cosmetic regulations.
We provide:
• Cosmetic product documentation
• Ingredient regulatory compliance review
• Cosmetic safety documentation
• Regulatory compliance support
Veterinary Product Registration
REGULATORY NEXUS GLOBAL also provides regulatory documentation services for veterinary pharmaceutical products exported to the United States, including:
• Veterinary drug documentation
• Regulatory compliance documentation
• Export regulatory 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
• FDA regulatory strategy planning
• Export regulatory documentation
North America Market Support
In addition to the United States, REGULATORY NEXUS GLOBAL supports regulatory documentation for North American markets, including:
• Canada
• Mexico
Our regulatory team ensures dossiers comply with international regulatory standards and country-specific requirements.
Why Choose REGULATORY NEXUS GLOBAL for US Regulatory Services
✔ Expertise in FDA regulatory systems
✔ CTD / eCTD compliant dossier preparation
✔ Experience in pharmaceutical and herbal product 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.