DossierTrans

Delhi NCR 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 regulatory consultants, corporate offices, importers, exporters, CROs, and pharmaceutical companies across Delhi NCR.

We support manufacturers, MA holders, importers, exporters, regulatory consultants, CROs, multinational subsidiaries, and government-facing regulatory teams in Delhi NCR with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, approvals, hearings, and post-approval compliance across India.

Who We Are

DossierTrans is a specialized regulatory translation service provider, focused exclusively on scientific, pharmaceutical, medical, food, and technical documentation for Indian regulatory submissions and global 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 / Central Government expectations

Regulatory Alignment – Delhi NCR / India

Our services are fully aligned with the requirements of:

• Central Drugs Standard Control Organization (CDSCO – HQ & Zonal Offices)
• Ministry of Health & Family Welfare (MoHFW)
• Food Safety and Standards Authority of India (FSSAI – HQ)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS – HQ)
• Drugs Controller (India) – DCGI Interface
• Import & Export Regulatory Authorities of India

Our Core Services – Delhi NCR

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• Regulatory correspondence, justifications & responses
• 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 – Delhi NCR

• CDSCO (HQ), DCGI & Central Authority queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations addressing official observations & deficiency letters
• Coordination with Delhi NCR–based consultants, legal teams, CROs & applicants

Languages We Support (Delhi NCR–Focused)

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

🌍 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 (as required by state or authority communication)

Foreign Language ↔ English | English ↔ Indian Languages

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

Industries We Serve – Delhi NCR

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Regulatory Consulting Firms
• CROs & Clinical Research
• Medical Devices & Diagnostics
• Biotechnology & Biosimilars
• Importers & Exporters
• Food, Nutraceuticals & Supplements
• Cosmetics & Personal Care Products

Why Choose DossierTrans in Delhi NCR?

✅ Strong understanding of CDSCO HQ & Central Authority workflows
✅ Proven experience with DCGI-facing submissions and responses
✅ Regulatory correspondence & justification expertise
✅ 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 Delhi NCR

Our Delhi NCR 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 central regulatory submission can delay approvals, trigger objections, or lead to rejection.

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

DossierTrans – Translating Science into Regulatory Approval from Delhi NCR