DossierTrans – Indonesia

Indonesia Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, technical review, and regulatory query support for Indonesia-specific dossiers and technical documents, aligned with Indonesian regulatory authorities and statutory requirements.

We support Indonesian manufacturers, importers, exporters, marketing authorization holders, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and regulatory approvals in Indonesia.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Indonesian market, focused exclusively on scientific, pharmaceutical, and technical documentation.

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers—not general translators.

We ensure every translated dossier maintains:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Indonesia-specific BPOM / MoH expectations

Indonesia Regulatory Alignment

Our services are aligned with the requirements of:

• Badan Pengawas Obat dan Makanan (BPOM) – National Agency of Drug and Food Control
• Ministry of Health (Kementerian Kesehatan – MoH)
• ASEAN Harmonized Technical Requirements (ACTD / ACTR)
• National Agency for Drug and Food Control Regulations
• Ministry of Trade (MoT)
• Directorate General of Customs and Excise (DGCE)
• Halal Product Assurance Agency (BPJPH) (where applicable)

Our Core Services – Indonesia

📘 Dossier & Technical Document Translation

• Indonesia-specific ACTD / non-ACTD dossier formats
• Administrative & technical dossier translations for BPOM submissions
• Labels, package inserts, leaflets & artwork text (Bahasa Indonesia–compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, import license & export documentation

🔍 Review of Translated Dossiers

• Scientific and technical review of translated documents
• Cross-verification with source-language dossiers
• Identification of terminology errors, inconsistencies & regulatory gaps
• Alignment with BPOM regulations, ACTD references, and local guidance

🛡️ Post-Submission Regulatory Query Handling – Indonesia

• BPOM / MoH queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations based on authority observations
• Coordination with applicants, consultants, local agents, and distributors

Languages We Support (Indonesia-Focused)

🌍 International Languages

• English
• French
• German
• Spanish
• Italian
• Portuguese
• Russian
• Arabic
• Chinese (Simplified & Traditional)
• Japanese
• Korean

🇮🇩 Local & Regional Language Support

• Bahasa Indonesia
• English (Indonesia regulatory format)

English ↔ Bahasa Indonesia | Foreign Language ↔ English / Bahasa Indonesia

All translations are reviewed by regulatory experts experienced with BPOM and ASEAN submission requirements.

Industries We Serve – Indonesia

• Pharmaceuticals & APIs
• Medical Devices
• Traditional & Herbal Medicines
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Indonesia?

✅ Indonesia-regulatory-focused translation (not generic translation)
✅ Proven expertise in BPOM & ASEAN ACTD documentation
✅ Native-language scientific & regulatory reviewers
✅ Terminology consistency across Indonesia submissions
✅ Authority-ready, inspection-friendly documentation
✅ End-to-end support including post-submission regulatory queries
✅ Strict confidentiality & data security

Global & Indonesia Regulatory Expertise

Our Indonesia services support:

• BPOM product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Export-support translations for ASEAN & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a BPOM approval.

That’s why we deliver precision-driven, regulator-acceptable translations, fully aligned with Indonesia compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Indonesia

If you’d like next, I can:
✔ Prepare SEO-optimized Indonesia landing page content
✔ Create Bahasa Indonesia–English bilingual brochures
✔ Develop BPOM-only pharma / cosmetics / food versions
✔ Convert this for Malaysia, Thailand, Vietnam, GCC, Africa, or LATAM