🇸🇬 Regulatory Affairs Services – Singapore
REGULATORY NEXUS GLOBAL
Singapore 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 professional regulatory affairs services and product registration support for Singapore.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Singapore regulatory framework and successfully registering their products for the Singapore market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Singapore regulatory authority requirements.
Singapore Regulatory Authority
Pharmaceuticals, biological products, medical devices, cosmetics and health supplements in Singapore are regulated by the Health Sciences Authority (HSA) under the Ministry of Health Singapore.
The authority is responsible for:
• Pharmaceutical product registration and approval
• Regulation of therapeutic products and biologics
• Regulation of medical devices and cosmetics
• Monitoring safety, quality and efficacy of healthcare products
• Pharmacovigilance and post-market surveillance
• Licensing of importers, manufacturers and wholesalers
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with HSA regulatory requirements.
Our Mission
To simplify Singapore regulatory compliance and enable companies to successfully register and market their products in Singapore through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Singapore
Pharmaceutical Product Registration
We prepare Singapore-compliant pharmaceutical regulatory dossiers for submission to the Health Sciences Authority.
Our services include preparation of:
• Administrative documentation
• Product formulation and composition details
• Manufacturing process documentation
• Quality control specifications and analytical methods
• Stability study reports
• Certificate of Pharmaceutical Product (CPP) documentation
• GMP documentation
• Bioequivalence documentation (where required)
All dossiers are prepared according to Singapore regulatory guidelines and international regulatory standards.
CTD / ASEAN Dossier Preparation
Singapore follows the ASEAN Common Technical Dossier (ACTD) and **Common Technical Document (CTD) formats for therapeutic product registration.
Our regulatory services include preparation of:
• Part I / Module 1 – Administrative Data and Product Information
• Part II / Module 2 – Quality Overall Summary
• Part III / Module 3 – Quality / CMC Documentation
• Part IV / Module 4 – Non-Clinical Documentation
• Part V / Module 5 – Clinical / Bioequivalence Documentation
Our regulatory experts ensure dossiers comply with ICH guidelines, ASEAN regulatory standards and HSA submission requirements.
Pharmaceutical Registration Process in Singapore
The general process for pharmaceutical product registration in Singapore includes:
Appointment of a local Singapore license holder or product registrant.
Submission of regulatory dossier through the HSA PRISM online regulatory system.
Technical evaluation of product quality, safety and efficacy.
Regulatory review and compliance assessment.
Approval and issuance of Therapeutic Product Registration by HSA.
The registration timeline typically ranges from 6–12 months depending on the evaluation pathway and product category.
Regulatory Services for Multiple Product Categories in Singapore
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Health Supplements
Health supplements in Singapore are regulated as complementary health products.
Our services include:
• Product technical documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation
Herbal & Traditional Medicine Products
Traditional medicines are regulated as Traditional Chinese Medicines (TCM) or complementary medicines.
We provide documentation support including:
• Herbal product regulatory dossiers
• Ingredient safety documentation
• Product technical documentation
• Export registration support
Cosmetics & Personal Care Products
Cosmetic products must comply with ASEAN Cosmetic Directive requirements before marketing in Singapore.
Our services include:
• Cosmetic Product Information File (PIF) preparation
• Cosmetic product notification through the HSA system
• Ingredient regulatory compliance verification
• Product safety documentation
Veterinary Products
• Veterinary drug regulatory dossiers
• Product technical documentation
• Export regulatory documentation
Additional Regulatory Support
REGULATORY NEXUS GLOBAL also provides:
• Technical scientific document writing
• Product development documentation
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for Singapore
Singapore Market Entry Support
Our regulatory experts assist companies seeking to enter the Singapore pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• ACTD / CTD dossier development
• HSA regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in Singapore HSA regulatory requirements
✔ ICH and ASEAN-compliant regulatory documentation
✔ Support from product development to registration
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions
About REGULATORY NEXUS GLOBAL
REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, providing global regulatory consultancy, export support and regulatory documentation services for pharmaceutical, herbal, nutraceutical and cosmetic products across international markets.