DossierTrans
Noida 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 manufacturers, biotech companies, CROs, regulatory consultancies, and export-oriented businesses based in Noida and Greater Noida.
We support manufacturers, MA holders, CROs, QA/RA teams, regulatory consultants, importers, exporters, and multinational subsidiaries in Noida 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, biotechnology, medical device, 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 / UP State Drug Control expectations
Regulatory Alignment – Noida / 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)
• Uttar Pradesh State Drug Control Administration
• Import & Export Regulatory Authorities of India
Our Core Services – Noida
📘 Dossier & Technical Document Translation
• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• Finished formulation dossiers (oral solids, injectables, biologics)
• Biotech, biosimilar & clinical documentation
• Medical device technical files, IFUs & labeling
• 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 – Noida
• CDSCO / UP State Drug Control queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations addressing official observations & hearing-stage requirements
• Coordination with Noida-based QA/RA teams, CROs & consultants
Languages We Support (Noida-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 and UP-specific regulations.
Industries We Serve – Noida & Greater Noida
We provide specialized translation and review services for:
• Pharmaceuticals & APIs
• Biotechnology & Biosimilars
• CROs & Clinical Research
• Medical Devices & Diagnostics
• Regulatory Consulting Firms
• Food, Nutraceuticals & Supplements
• Cosmetics & Personal Care Products
Why Choose DossierTrans in Noida?
✅ Strong understanding of Noida’s pharma, biotech & CRO ecosystem
✅ Proven experience with CDSCO & UP State Drug Control submissions
✅ Expertise in formulation, biotech & clinical 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 Noida
Our Noida 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 formulation, biotech, or regulatory dossier can delay approvals, trials, or market entry.
That’s why we deliver precision-driven, regulator-acceptable translations, trusted by Noida’s pharmaceutical, biotech, and regulatory community.
DossierTrans – Translating Science into Regulatory Approval from Noida