DossierTrans
Gurgaon (Gurugram) 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 corporate offices, regulatory consultancies, CROs, importers, exporters, and multinational companies based in Gurgaon.
We support Marketing Authorization Holders (MAHs), regulatory consultants, CROs, multinational subsidiaries, importers, exporters, and compliance teams in Gurgaon with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, 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 & Haryana State expectations
Regulatory Alignment – Gurgaon / India
Our services are fully aligned with the requirements of:
• Central Drugs Standard Control Organization (CDSCO)
• Drugs Controller General of India (DCGI)
• Ministry of Health & Family Welfare (MoHFW)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS)
• Haryana State Drug Control Administration
• Import & Export Regulatory Authorities of India
Our Core Services – Gurgaon
📘 Dossier & Technical Document Translation
• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• Regulatory correspondence, justifications & deficiency 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 – Gurgaon
• CDSCO / DCGI / Central Authority queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations addressing official observations & hearing-stage requirements
• Coordination with Gurgaon-based consultants, legal teams, CROs & applicants
Languages We Support (Gurgaon-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 Language Support
• English (Indian regulatory format)
• Hindi
• Other regional languages – on request
Foreign Language ↔ English | English ↔ Indian Languages
All translations are reviewed by scientific and regulatory experts familiar with Indian central regulatory processes.
Industries We Serve – Gurgaon
We provide specialized translation and review services for:
• Pharmaceuticals & APIs
• Regulatory Consulting Firms
• CROs & Clinical Research
• Biotechnology & Biosimilars
• Medical Devices & Diagnostics
• Importers & Exporters
• Food, Nutraceuticals & Supplements
• Cosmetics & Personal Care Products
Why Choose DossierTrans in Gurgaon?
✅ Strong understanding of corporate-HQ and regulatory-consulting workflows
✅ Proven experience with CDSCO & DCGI-facing submissions
✅ Regulatory correspondence & deficiency-response 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 Gurgaon
Our Gurgaon 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 deficiency response can delay approvals or trigger objections.
That’s why we deliver precision-driven, regulator-acceptable translations, trusted by Gurgaon’s corporate, regulatory, and international trade ecosystem.
DossierTrans – Translating Science into Regulatory Approval from Gurgaon