DossierTrans

Ahmedabad 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 and industrial companies based in Ahmedabad and Gujarat.

We support manufacturers, exporters, importers, CROs, consultants, and regulatory teams in Ahmedabad 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, and technical documentation for Indian regulatory submissions.

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 expectations

Regulatory Alignment – Ahmedabad / India

Our services are fully aligned with the requirements of:

• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS)
• Gujarat State FDCA
• Import & Export Regulatory Authorities of India

Our Core Services – Ahmedabad

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• SmPC, PIL, labels, leaflets & artwork text (India-compliant)
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS & 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 guidelines & ICH references

🛡️ Post-Submission Regulatory Query Handling – Ahmedabad

• CDSCO / State FDA queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations as per authority observations
• Coordination with Ahmedabad-based manufacturers, consultants & agents

Languages We Support (Ahmedabad-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
• Other regional languages – on request (as per state authority requirements)

Foreign Language ↔ English | English ↔ Indian Languages

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

Industries We Serve – Ahmedabad & Gujarat

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• CROs & Clinical Research Organizations
• Biotechnology & Life Sciences
• Cosmetics & Personal Care
• Herbal, Ayurveda & Natural Products
• Chemicals & Specialty Chemicals
• Food & Nutraceutical Ingredients

Why Choose DossierTrans in Ahmedabad?

✅ Ahmedabad-centric support with national regulatory expertise
✅ Proven experience with CDSCO & Gujarat FDCA submissions
✅ Native-language scientific reviewers
✅ Terminology consistency across Indian dossiers
✅ Authority-ready documentation
✅ End-to-end support including post-approval queries
✅ Strict confidentiality & data security

India & Global Regulatory Support from Ahmedabad

Our Ahmedabad services support:

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

Our Commitment

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

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

DossierTrans – Translating Science into Regulatory Approval from Ahmedabad