Regulatory Affairs Services in Asia
REGULATORY NEXUS GLOBAL
Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products in Asia
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 across Asia.
Asia is one of the fastest-growing pharmaceutical and healthcare markets in the world, with each country having its own regulatory authority and product registration requirements. Our regulatory experts support companies in navigating complex Asian regulatory frameworks and preparing compliant regulatory dossiers for product approvals across Asian markets.
We provide end-to-end regulatory documentation, dossier preparation and regulatory strategy support for companies seeking market entry in Asia.
Regulatory Authorities in Asia
Product registration in Asian countries is regulated by national regulatory agencies such as:
• Central Drugs Standard Control Organization (India)
• National Medical Products Administration (China)
• Pharmaceuticals and Medical Devices Agency (Japan)
• Health Sciences Authority (Singapore)
• Thai Food and Drug Administration (Thailand)
• National Pharmaceutical Regulatory Agency (Malaysia)
• Food and Drug Administration Philippines (Philippines)
• Directorate General of Drug Administration (Bangladesh)
REGULATORY NEXUS GLOBAL prepares country-specific regulatory dossiers aligned with the requirements of each Asian regulatory authority.
Our Mission
Our mission is to simplify regulatory compliance across Asian markets and enable companies to successfully register and commercialize their pharmaceutical, nutraceutical, herbal and cosmetic products in Asia through scientifically sound regulatory documentation.
Core Regulatory Services for Asia
CTD Dossier Preparation
We prepare Common Technical Document (CTD) dossiers according to ICH guidelines, which are widely accepted across many Asian regulatory agencies.
Our CTD dossier preparation includes:
• Module 1 – Administrative and regional information
• Module 2 – Quality Overall Summary (QOS) and expert summaries
• Module 3 – Quality / CMC documentation
• Module 4 – Non-clinical study reports (where required)
• Module 5 – Clinical study reports / Bioequivalence reports
All documentation is prepared in accordance with ICH, WHO and country-specific regulatory expectations.
ACTD Dossier Preparation for ASEAN Countries
For Southeast Asian markets, we prepare ASEAN Common Technical Dossier (ACTD) for product registration in countries such as:
• Thailand
• Vietnam
• Malaysia
• Philippines
• Indonesia
• Cambodia
• Laos
• Myanmar
Our ACTD dossiers include complete Part I, II, III and IV documentation aligned with ASEAN regulatory requirements.
Regulatory Services for Multiple Product Categories
REGULATORY NEXUS GLOBAL provides regulatory documentation services for multiple regulated product categories across Asia.
Pharmaceutical Products
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• Regulatory submission documentation
Nutraceuticals & Food Supplements
• Nutraceutical export registration dossiers
• Ingredient regulatory compliance documentation
• Product formulation documentation
• Technical regulatory dossiers
Herbal & Traditional Medicine Products
Asia has strong regulatory frameworks for traditional medicine. We prepare documentation for:
• Herbal medicine dossiers
• Traditional medicine regulatory documentation
• Botanical ingredient compliance documentation
• Export regulatory support
Cosmetics & Cosmeceuticals
• Cosmetic Product Information File (PIF)
• Cosmetic export registration dossiers
• Ingredient regulatory compliance documentation
• Cosmetic labeling compliance documentation
Veterinary Products
• Veterinary drug registration dossiers
• Veterinary product technical documentation
• Export regulatory documentation
Additional Regulatory Support
REGULATORY NEXUS GLOBAL also provides:
• Technical document writing
• Product development reports
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence report documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for Asian markets
Asian Market Coverage
REGULATORY NEXUS GLOBAL supports regulatory documentation and product registration in major Asian markets including:
• India
• China
• Japan
• South Korea
• Bangladesh
• Vietnam
• Thailand
• Malaysia
• Indonesia
• Philippines
• Singapore
• Sri Lanka
• Nepal
• Myanmar
• Cambodia
• Laos
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in multiple Asian regulatory frameworks
✔ ICH-compliant dossier preparation
✔ Regulatory documentation for pharmaceuticals, nutraceuticals, herbal and cosmetics
✔ Country-specific regulatory strategies
✔ End-to-end regulatory support for Asian markets
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 across Asia and other regulated global markets.