DossierTrans – India

India 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 India-specific dossiers and technical documents, strictly aligned with Indian regulatory authorities and statutory requirements.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Indian 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 preserves:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with India-specific CDSCO / FSSAI / AYUSH expectations

Indian Regulatory Alignment

Our services are aligned with the requirements of:

• Central Drugs Standard Control Organization (CDSCO)
• State Drug Control Authorities (State FDAs)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS)
• Indian Pharmacopoeia Commission (IPC)
• Import & Export regulatory agencies in India

Our Core Services – India

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• SmPC, PIL, labels, package inserts, leaflets & artwork text (India-compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Import registration, manufacturing 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 & compliance gaps
• Alignment with Indian Pharmacopoeia (IP) and CDSCO regulatory references

🛡️ Post-Submission Regulatory Query Handling – India

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

Languages We Support (India-Focused)

🌍 International Languages

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

🇮🇳 Indian & Regional Language Support

• Hindi
• English (Indian regulatory format)
• Other regional languages – on request, as per state authority requirements

English ↔ Hindi | Foreign Language ↔ English / Hindi

All translations are reviewed by scientific and regulatory experts experienced with Indian regulations.

Industries We Serve – India

• Pharmaceuticals & APIs
• Cosmetics & Personal Care
• Herbal, Ayurveda & Natural Extracts
• Essential Oils & Fragrances
• Food & Nutraceutical Ingredients
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose DossierTrans for India?

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

Global & India Regulatory Expertise

Our India services support:

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

Our Commitment

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

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

DossierTrans – Translating Science into Regulatory Approval in India

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