🇮🇳 Regulatory Affairs Services – Roorkee
REGULATORY NEXUS GLOBAL
Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Companies in Roorkee
REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, providing global regulatory affairs services for pharmaceutical, nutraceutical, herbal and cosmetic companies in Roorkee.
Roorkee is part of the rapidly growing pharmaceutical manufacturing corridor of Uttarakhand, which includes industrial clusters around Haridwar and Dehradun. The region hosts numerous pharmaceutical formulation manufacturers, nutraceutical companies, herbal product manufacturers and contract manufacturing facilities supplying medicines to both domestic and export markets.
REGULATORY NEXUS GLOBAL supports companies in Roorkee with international regulatory documentation, CTD dossier preparation and global product registration services.
Our Mission
To support pharmaceutical and healthcare manufacturers in Roorkee with scientifically compliant regulatory documentation and help them successfully register and export their products to regulated international markets.
Regulatory Affairs Services for Roorkee Pharmaceutical Companies
We provide regulatory consulting and documentation services to pharmaceutical manufacturers, nutraceutical companies, herbal product manufacturers and cosmetic companies in Roorkee.
Our services include:
• CTD dossier preparation
• ACTD dossier preparation
• Country-specific regulatory dossiers
• Export registration documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Regulatory submission support
Our Core Regulatory Services
CTD Dossier Preparation
We prepare Common Technical Document (CTD) dossiers according to ICH guidelines for pharmaceutical product registration in international markets.
CTD Modules include:
• Module 1 – Regional administrative information
• Module 2 – Quality overall summary and expert reports
• Module 3 – Quality / CMC documentation
• Module 4 – Non-clinical study reports (where applicable)
• Module 5 – Clinical study reports / bioequivalence documentation
Our team ensures compliance with WHO, US FDA, EMA and other international regulatory authority requirements.
ACTD Dossier Preparation
For companies exporting to ASEAN markets, we prepare ASEAN Common Technical Dossier (ACTD) including:
• Part I – Administrative documentation
• Part II – Quality documentation
• Part III – Non-clinical documentation
• Part IV – Clinical documentation
ACTD dossiers are prepared for markets such as:
• Thailand
• Vietnam
• Malaysia
• Philippines
• Indonesia
• Cambodia
• Myanmar
Regulatory Documentation for Export Markets
REGULATORY NEXUS GLOBAL prepares country-specific regulatory dossiers for pharmaceutical companies exporting to global markets including:
• Africa (ROW markets)
• Middle East
• CIS countries
• ASEAN markets
• Latin America
• European markets
Regulatory Services for Multiple Product Categories
Pharmaceuticals
Services include:
• Generic drug dossiers
• CMC documentation
• API documentation and DMF preparation
• Bioequivalence documentation
• Regulatory submission support
Nutraceuticals & Food Supplements
We prepare documentation for:
• Nutraceutical export registration dossiers
• Ingredient regulatory compliance documentation
• Technical product documentation
• Label compliance review
Herbal & Ayurvedic Products
Services include:
• Herbal product registration dossiers
• Traditional medicine regulatory documentation
• Export regulatory compliance
• Ingredient safety documentation
Cosmetics & Cosmeceuticals
We prepare:
• Cosmetic Product Information File (PIF)
• Cosmetic export registration dossiers
• Ingredient regulatory compliance documentation
• Product safety documentation
Veterinary Products
Services include:
• Veterinary drug registration dossiers
• Export regulatory documentation
• Technical documentation preparation
Additional Technical & Regulatory Support
We also provide:
• Technical document writing
• Product development reports
• Analytical method validation documentation (ICH guidelines)
• Clinical trial report writing
• Bioequivalence report documentation
• Regulatory gap analysis
• Global regulatory strategy planning
Global Regulatory Market Support
Companies in Roorkee export pharmaceutical and healthcare products worldwide.
REGULATORY NEXUS GLOBAL supports regulatory submissions in:
• Africa
• Middle East
• ASEAN
• Europe
• CIS countries
• Latin America
Our regulatory experts ensure dossiers meet international regulatory authority requirements.
Why Choose REGULATORY NEXUS GLOBAL
✔ Expertise in global regulatory affairs
✔ ICH-compliant dossier preparation
✔ Experience with multiple international regulatory markets
✔ Scientific and regulatory documentation expertise
✔ End-to-end regulatory solutions
✔ Support from product development to global product registration
About REGULATORY NEXUS GLOBAL
REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd.
We specialize in global regulatory affairs, export documentation and product registration services for pharmaceutical, nutraceutical, herbal, veterinary and cosmetic products.