DossierTrans

Ankleshwar 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, and chemical manufacturers based in Ankleshwar GIDC and surrounding industrial areas.

We support manufacturers, exporters, importers, traders, CROs, consultants, and regulatory teams in Ankleshwar 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 and export-oriented 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 / Gujarat FDCA expectations

Regulatory Alignment – Ankleshwar / 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 Food & Drugs Control Administration (FDCA)
• Import & Export Regulatory Authorities of India

Our Core Services – Ankleshwar

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• API & intermediate dossiers for domestic and export markets
• 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 guidelines & ICH references

🛡️ Post-Submission Regulatory Query Handling – Ankleshwar

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

Languages We Support (Ankleshwar-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
• Gujarati – 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 Gujarat-specific regulations.

Industries We Serve – Ankleshwar Industrial Cluster

We provide specialized translation and review services for:

• APIs & Intermediates
• Pharmaceuticals (Formulations)
• Specialty & Industrial Chemicals
• Agrochemicals
• Dyes & Pigments
• CROs & Contract Manufacturing Organizations
• Export-oriented manufacturing units

Why Choose DossierTrans in Ankleshwar?

✅ Deep understanding of Ankleshwar GIDC industrial requirements
✅ Proven experience with CDSCO & Gujarat FDCA submissions
✅ API- and chemical-focused regulatory translation expertise
✅ 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 Ankleshwar

Our Ankleshwar services support:

• Domestic Indian regulatory submissions
• Export dossiers for US FDA, EU, 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 an API or technical dossier can delay plant approvals, exports, or regulatory clearances.

That’s why we deliver precision-driven, regulator-acceptable translations, trusted by Ankleshwar’s pharmaceutical and chemical manufacturing ecosystem.

DossierTrans – Translating Science into Regulatory Approval from Ankleshwar