DossierTrans

Faridabad 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, chemical, and export-oriented manufacturing units based in Faridabad.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider, focused exclusively on scientific, pharmaceutical, medical device, chemical, 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 / Haryana State Drug Control expectations

Regulatory Alignment – Faridabad / 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)
• Haryana State Drug Control Administration
• Import & Export Regulatory Authorities of India

Our Core Services – Faridabad

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• Finished formulation and API dossiers
• 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 – Faridabad

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

Languages We Support (Faridabad-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 Language Support

• English (Indian regulatory format)
• Hindi
• Regional languages – on request, as required

Foreign Language ↔ English | English ↔ Indian Languages

All translations are reviewed by scientific and regulatory experts familiar with Indian and Haryana-specific regulations.

Industries We Serve – Faridabad Industrial Hub

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Medical Devices & Diagnostics
• Industrial & Specialty Chemicals
• Engineering & Export-Oriented Units
• Cosmetics & Personal Care Products
• Herbal, AYUSH & Natural Products
• Food, Nutraceuticals & Supplements

Why Choose DossierTrans in Faridabad?

✅ Strong understanding of Faridabad’s manufacturing ecosystem
✅ Proven experience with CDSCO & Haryana State Drug Control submissions
✅ Expertise across pharma, devices & technical 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 Faridabad

Our Faridabad 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 technical dossier can delay inspections, approvals, or exports.

That’s why we deliver precision-driven, regulator-acceptable translations, trusted by Faridabad’s pharmaceutical and industrial community.

DossierTrans – Translating Science into Regulatory Approval from Faridabad