🇮🇩 Regulatory Affairs Services – Indonesia
REGULATORY NEXUS GLOBAL
Indonesia 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 Indonesia.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Indonesian regulatory system and successfully registering their products for the Indonesian market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Indonesian regulatory authority requirements.
Indonesia Regulatory Authority
Pharmaceutical products, traditional medicines, nutraceuticals and cosmetics in Indonesia are regulated by the National Agency of Drug and Food Control, commonly known as BPOM (Badan Pengawas Obat dan Makanan).
BPOM is responsible for:
• Registration and approval of pharmaceutical products
• Regulation of traditional medicines and herbal products
• Control of nutraceuticals and health supplements
• Regulation of cosmetic products
• Post-marketing surveillance and safety monitoring
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with BPOM regulatory requirements.
Our Mission
To simplify Indonesia regulatory compliance and enable companies to successfully register and market their products in Indonesia through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Indonesia
Pharmaceutical Product Registration Dossiers
We prepare Indonesia-compliant pharmaceutical registration dossiers for submission to BPOM.
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 in accordance with BPOM regulatory guidelines and international standards.
ACTD Dossier Preparation for Indonesia
Indonesia follows the ASEAN Common Technical Dossier (ACTD) format for pharmaceutical product registration.
Our ACTD dossier preparation services include:
• Part I – Administrative Data and Product Information
• Part II – Quality Documentation (CMC)
• Part III – Non-Clinical Documentation
• Part IV – Clinical Documentation
Our regulatory team ensures dossiers comply with ASEAN regulatory standards and BPOM submission requirements.
Regulatory Services for Multiple Product Categories in Indonesia
Pharmaceuticals
• Generic drug registration dossiers
• API documentation support
• Bioequivalence documentation
• CMC documentation
• Stability documentation
• GMP compliance documentation
Nutraceuticals & Health Supplements
Indonesia has a rapidly growing nutraceutical and health supplement market.
Our services include:
• Product technical documentation
• Ingredient regulatory compliance verification
• Product specification documentation
• Label compliance documentation
• Export regulatory documentation
Herbal & Traditional Medicine Products
Indonesia has a strong traditional herbal medicine sector known as Jamu.
We provide regulatory documentation support for herbal products including:
• Herbal product regulatory dossiers
• Traditional medicine documentation
• Ingredient safety documentation
• Export registration support
Cosmetics & Personal Care Products
Cosmetic products require BPOM notification and compliance before marketing.
Our services include:
• Cosmetic product information documentation
• Ingredient regulatory compliance verification
• Cosmetic product notification documentation
• 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 Indonesia
Indonesia Market Entry Support
Our regulatory experts assist companies seeking to enter the Indonesian healthcare market through:
• Regulatory documentation preparation
• ACTD-compliant dossier development
• BPOM regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in Indonesia BPOM requirements
✔ ACTD-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.
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