DossierTrans

Hyderabad 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 majors, API manufacturers, biotech firms, CROs, and R&D centers based in Hyderabad.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider, focused exclusively on scientific, pharmaceutical, API, biotechnology, 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 / Telangana State FDA expectations

Regulatory Alignment – Hyderabad / 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)
• Telangana State Drugs Control Administration
• Import & Export Regulatory Authorities of India

Our Core Services – Hyderabad

📘 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
• Finished formulation dossiers (oral solids, injectables, biologics)
• Biotech, biosimilar & fermentation-based product 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 – Hyderabad

• CDSCO / Telangana State FDA queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations as per authority observations
• Coordination with Hyderabad-based QA/RA teams, CROs & regulatory consultants

Languages We Support (Hyderabad-Focused)

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

🌍 International Languages

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

🇮🇳 Indian & Regional Language Support

• English (Indian regulatory format)
• Hindi
• Telugu – 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 Telangana-specific regulations.

Industries We Serve – Hyderabad Pharma & Biotech Hub

We provide specialized translation and review services for:

• APIs & Intermediates
• Pharmaceutical Finished Dosage Forms
• Biotechnology, Biosimilars & Vaccines
• CROs & Clinical Research
• Specialty & Fine Chemicals
• Herbal, AYUSH & Natural Products
• Food, Nutraceuticals & Supplements

Why Choose DossierTrans in Hyderabad?

✅ Deep understanding of Hyderabad’s global pharma & API ecosystem
✅ Proven experience with CDSCO & Telangana State FDA submissions
✅ API-, biotech- & formulation-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 Hyderabad

Our Hyderabad 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 an API, biotech, or formulation dossier can delay approvals, inspections, or global launches.

That’s why we deliver precision-driven, regulator-acceptable translations, trusted by Hyderabad’s pharmaceutical and life-sciences ecosystem.

DossierTrans – Translating Science into Regulatory Approval from Hyderabad