DossierTrans

Bangalore 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, biotech, CRO, medical device, and life-science companies based in Bangalore.

We support manufacturers, R&D centers, biotech startups, CROs, regulatory consultants, exporters, and multinational subsidiaries in Bangalore 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, biotechnology, medical device, and technical documentation.

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 / Karnataka State FDA expectations

Regulatory Alignment – Bangalore / 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)
• Karnataka State Drugs Control Department
• Import & Export Regulatory Authorities of India

Our Core Services – Bangalore

📘 Dossier & Technical Document Translation

• India-specific CTD / non-CTD dossier formats
• Module 1–5 translations for CDSCO submissions
• Clinical trial, BA/BE & bioanalytical documentation
• Biotech, biologics & biosimilar dossiers
• Medical device technical files & IFUs
• 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 – Bangalore

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

Languages We Support (Bangalore-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 Language Support

• English (Indian regulatory format)
• Hindi
• Kannada – where required for state-specific or local documentation

Foreign Language ↔ English | English ↔ Indian / Regional Languages

All translations are reviewed by scientific and regulatory experts familiar with Indian and Karnataka-specific regulations.

Industries We Serve – Bangalore Life-Sciences Hub

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Biotechnology & Biosimilars
• Clinical Research Organizations (CROs)
• Medical Devices & Diagnostics
• Digital Health & Combination Products
• Cosmetics & Personal Care
• Herbal, AYUSH & Natural Products
• Food, Nutraceuticals & Supplements

Why Choose DossierTrans in Bangalore?

✅ Strong understanding of Bangalore’s R&D-driven regulatory ecosystem
✅ Proven experience with CDSCO & Karnataka State FDA submissions
✅ Expertise across pharma, biotech, clinical & medical device documentation
✅ Native-language scientific reviewers
✅ Terminology consistency across Indian and global dossiers
✅ Authority-ready documentation
✅ End-to-end support including post-approval queries
✅ Strict confidentiality & data security

India & Global Regulatory Support from Bangalore

Our Bangalore services support:

• Domestic Indian regulatory submissions
• Export-oriented 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 a clinical, biotech, or technical dossier can delay approvals, trials, or global market entry.

That’s why we deliver precision-driven, regulator-acceptable translations, trusted by Bangalore’s pharmaceutical, biotech, and life-science community.

DossierTrans – Translating Science into Regulatory Approval from Bangalore