DossierTrans

Mumbai 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 head offices, manufacturers, CROs, regulatory consultancies, and import–export companies based in Mumbai and the Mumbai Metropolitan Region (MMR).

We support manufacturers, Marketing Authorization Holders (MAHs), importers, exporters, CROs, regulatory consultants, QA/RA teams, and multinational subsidiaries in Mumbai with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, approvals, hearings, 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, medical device, food, and technical documentation for Indian regulatory submissions and international filings.

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 / Maharashtra FDA expectations

Regulatory Alignment – Mumbai / 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)
• Maharashtra State Food & Drug Administration (FDA)
• Import & Export Regulatory Authorities of India

Our Core Services – Mumbai

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• Regulatory correspondence, justifications & hearing documents
• SmPC, PIL, labels, leaflets & artwork text (India-compliant)
• Clinical trial, BA/BE & bioanalytical documentation
• 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 – Mumbai

• CDSCO / Maharashtra FDA queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations addressing official observations & hearing-stage requirements
• Coordination with Mumbai-based QA/RA teams, consultants & legal representatives

Languages We Support (Mumbai-Focused)

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

🌍 International Languages

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

🇮🇳 Indian & Regional Language Support

• English (Indian regulatory format)
• Hindi
• Marathi – 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 Maharashtra-specific regulations.

Industries We Serve – Mumbai & Maharashtra

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Regulatory Consulting & Corporate HQs
• CROs & Clinical Research
• Biotechnology & Biosimilars
• Medical Devices & Diagnostics
• Food, Nutraceuticals & Supplements
• Cosmetics & Personal Care Products
• Import–Export & Trading Companies

Why Choose DossierTrans in Mumbai?

✅ Strong understanding of Mumbai’s regulatory, corporate & export ecosystem
✅ Proven experience with CDSCO & Maharashtra FDA submissions
✅ Expertise in regulatory correspondence & hearing documentation
✅ Native-language scientific reviewers
✅ Terminology consistency across Indian and global dossiers
✅ Authority-ready documentation
✅ End-to-end support including post-approval & hearing-stage queries
✅ Strict confidentiality & data security

India & Global Regulatory Support from Mumbai

Our Mumbai services support:

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

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence in a regulatory submission or hearing document can delay approvals or impact market access.

That’s why we deliver precision-driven, regulator-acceptable translations, trusted by Mumbai’s pharmaceutical, regulatory, and international trade ecosystem.

DossierTrans – Translating Science into Regulatory Approval from Mumbai