🇨🇳 Regulatory Affairs Services in China
REGULATORY NEXUS GLOBAL
Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products in China
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 China.
China is one of the largest pharmaceutical and healthcare markets in the world, with a highly structured regulatory system for medicines, medical products, nutraceuticals and cosmetics. Companies planning to export products to China must comply with strict regulatory requirements, product approval procedures, and technical documentation standards.
REGULATORY NEXUS GLOBAL supports international manufacturers by preparing China-compliant regulatory dossiers, CTD documentation and scientific technical files required for successful product registration and regulatory approval.
Regulatory Authority in China
Medicinal products and healthcare products in China are regulated by the National Medical Products Administration (NMPA).
The authority evaluates product quality, safety, efficacy, manufacturing standards, clinical data and regulatory documentation before granting product registration and market authorization.
REGULATORY NEXUS GLOBAL assists companies in preparing regulatory dossiers aligned with NMPA regulatory guidelines and international pharmaceutical standards.
Our Mission
Our mission is to simplify regulatory compliance for the Chinese pharmaceutical and healthcare market and enable companies to successfully register and commercialize pharmaceutical, nutraceutical, herbal and cosmetic products in China through scientifically sound regulatory documentation.
Core Regulatory Services for China
CTD Dossier Preparation
Pharmaceutical product registration in China follows the Common Technical Document (CTD) format aligned with ICH guidelines and NMPA regulatory requirements.
Our CTD dossier preparation services include:
• Module 1 – Administrative and regional information
• 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 NMPA guidelines and international pharmaceutical standards.
Regulatory Services for Multiple Product Categories
Pharmaceutical Products
• Generic drug registration dossiers
• CTD dossier preparation
• API documentation and Drug Master File (DMF) support
• Bioequivalence documentation
• CMC technical documentation
• Stability study documentation
• Regulatory submission documentation
Nutraceuticals & Health Supplements
Health supplements in China are regulated as Health Foods and must comply with regulatory requirements of the National Medical Products Administration.
Our services include:
• Health supplement regulatory documentation
• Ingredient compliance verification
• Product formulation documentation
• Export registration documentation
Herbal & Traditional Chinese Medicine Products
China has a well-established regulatory framework for Traditional Chinese Medicine (TCM) and herbal medicinal products.
Our services include:
• Herbal medicine regulatory dossiers
• Botanical ingredient documentation
• Traditional medicine regulatory documentation
• Export regulatory support
Cosmetics & Cosmeceuticals
Cosmetics marketed in China must comply with regulations administered by the National Medical Products Administration.
Our services include:
• Cosmetic Product Information File (PIF)
• Cosmetic safety documentation
• Cosmetic regulatory compliance documentation
• Ingredient regulatory compliance
• Cosmetic product registration support
Veterinary Products
Veterinary medicines and animal health products require regulatory approval before import and marketing.
Our services include:
• Veterinary medicinal product dossiers
• Veterinary regulatory documentation
• Export regulatory compliance support
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 China
Asia-Pacific Market Support
REGULATORY NEXUS GLOBAL supports regulatory documentation and product registration across Asia-Pacific markets, including:
• China
• India
• Japan
• South Korea
• Singapore
• Malaysia
• Thailand
• Vietnam
• Indonesia
• Philippines
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in CTD dossier preparation
✔ Compliance with NMPA regulatory frameworks
✔ Regulatory support for pharmaceuticals, nutraceuticals, herbal and cosmetics
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions for China market entry
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 China and other regulated global markets.