DossierTrans

Indore 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, nutraceutical, and contract manufacturing units based in Indore and central India.

We support manufacturers, exporters, importers, contract manufacturers, QA/RA teams, CROs, and regulatory consultants in Indore 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, food, 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 / MP State Drug Control expectations

Regulatory Alignment – Indore / 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)
• Madhya Pradesh State Drugs Control Administration
• Import & Export Regulatory Authorities of India

Our Core Services – Indore

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• Finished formulation dossiers (tablets, capsules, syrups, injectables)
• API & excipient documentation
• 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 – Indore

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

Languages We Support (Indore-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

Foreign Language ↔ English | English ↔ Indian Languages

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

Industries We Serve – Indore Pharma & Manufacturing Hub

We provide specialized translation and review services for:

• Pharmaceutical Finished Dosage Forms
• APIs & Excipients
• Contract & Third-Party Manufacturing
• Herbal, AYUSH & Natural Products
• Food, Nutraceuticals & Supplements
• Specialty & Industrial Chemicals

Why Choose DossierTrans in Indore?

✅ Strong understanding of Indore’s pharmaceutical manufacturing ecosystem
✅ Proven experience with CDSCO & MP State Drug Control submissions
✅ Expertise across formulations, APIs & nutraceutical 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 Indore

Our Indore 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 formulation or manufacturing dossier can delay approvals, inspections, or market entry.

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

DossierTrans – Translating Science into Regulatory Approval from Indore