DossierTrans

Chennai Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for India-specific dossiers and technical documents, with dedicated service support for pharmaceutical, API, medical device, and export-oriented manufacturing companies based in Chennai and Tamil Nadu.

We support manufacturers, exporters, importers, CROs, regulatory consultants, QA/RA teams, and multinational subsidiaries in Chennai with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, approvals, and post-approval compliance across India and international markets.

Who We Are

DossierTrans is a specialized regulatory translation service provider, focused exclusively on scientific, pharmaceutical, medical device, and technical documentation for Indian regulatory submissions and export dossiers.

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

We ensure that translated dossiers consistently maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with CDSCO / FSSAI / AYUSH / BIS / Tamil Nadu Drugs Control expectations

Regulatory Alignment – Chennai / India

Our services are fully aligned with the requirements of:

• Central Drugs Standard Control Organization (CDSCO)
• Ministry of Health & Family Welfare (MoHFW)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS)
• Tamil Nadu Drugs Control Department
• Import & Export Regulatory Authorities of India

Our Core Services – Chennai

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• Finished formulation dossiers (oral solids, injectables, ophthalmics, biologics, etc.)
• API & excipient documentation
• Medical device technical files, IFUs & labeling
• SmPC, PIL, labels, leaflets & artwork text (India-compliant)
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS, MSDS & technical files
• Import registration, manufacturing license & MA documentation

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents
• Cross-verification with source dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with Indian Pharmacopoeia (IP), CDSCO guidance, ICH & WHO references

🛡️ Post-Submission Regulatory Query Handling – Chennai

• CDSCO / Tamil Nadu Drugs Control queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations as per authority observations
• Coordination with Chennai-based manufacturing units, QA/RA teams & consultants

Languages We Support (Chennai-Focused)

We provide professional, native-level regulatory translations relevant to Indian submissions and exports:

🌍 International Languages

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

🇮🇳 Indian & Regional Language Support

• English (Indian regulatory format)
• Hindi
• Tamil – where required for state or local documentation

Foreign Language ↔ English | English ↔ Indian / Regional Languages

All translations are reviewed by scientific and regulatory experts familiar with Indian and Tamil Nadu–specific regulations.

Industries We Serve – Chennai & Tamil Nadu

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Contract Manufacturing & Export Units
• Medical Devices & Diagnostics
• Biotechnology & Biologics
• CROs & Clinical Research
• Cosmetics & Personal Care
• Herbal, AYUSH & Traditional Medicines
• Food, Nutraceuticals & Supplements

Why Choose DossierTrans in Chennai?

✅ Strong understanding of Chennai’s manufacturing and export ecosystem
✅ Proven experience with CDSCO & Tamil Nadu Drugs Control submissions
✅ Expertise in formulations, APIs & medical device documentation
✅ Native-language scientific reviewers
✅ Terminology consistency across Indian and export dossiers
✅ Authority-ready documentation
✅ End-to-end support including post-approval queries
✅ Strict confidentiality & data security

India & Global Regulatory Support from Chennai

Our Chennai services support:

• Domestic Indian regulatory submissions
• Export dossiers for US FDA, EU, UK, Canada, GCC & ROW markets
• Import registration and compliance documentation
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence in a manufacturing or export dossier can delay inspections, approvals, or international shipments.

That’s why we deliver precision-driven, regulator-acceptable translations, trusted by Chennai’s pharmaceutical, medical device, and life-science industries.

DossierTrans – Translating Science into Regulatory Approval from Chennai