DossierTrans – Sri Lanka

Sri Lanka Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, technical review, and regulatory query support for Sri Lanka–specific dossiers and technical documents, aligned with Sri Lankan regulatory authorities and statutory requirements.

We support Sri Lankan manufacturers, importers, exporters, marketing authorization holders, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and regulatory approvals in Sri Lanka.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Sri Lankan market, focused exclusively on scientific, pharmaceutical, and technical documentation.

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers—not general translators.

We ensure every translated dossier preserves:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Sri Lanka–specific NMRA / MoH expectations

Sri Lanka Regulatory Alignment

Our services are aligned with the requirements of:

• National Medicines Regulatory Authority (NMRA)
• Ministry of Health (MoH), Sri Lanka
• NMRA Act No. 5 of 2015 & related regulations
• Sri Lanka Pharmacopoeia / NMRA-accepted international pharmacopoeias (IP, BP, USP, EP)
• Department of Import & Export Control
• Sri Lanka Customs
• Other applicable import & export regulatory authorities in Sri Lanka

Our Core Services – Sri Lanka

📘 Dossier & Technical Document Translation

• Sri Lanka–specific CTD / non-CTD dossier formats
• Module 1–5 translations for NMRA submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (Sinhala / Tamil / English compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, import license & export documentation

🔍 Review of Translated Dossiers

• Scientific and technical review of translated documents
• Cross-verification with source-language dossiers
• Identification of terminology errors, inconsistencies & regulatory gaps
• Alignment with NMRA guidelines, Sri Lanka Pharmacopoeia, and MoH references

🛡️ Post-Submission Regulatory Query Handling – Sri Lanka

• NMRA / MoH queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations based on authority observations
• Coordination with applicants, consultants, local agents, and distributors

Languages We Support (Sri Lanka-Focused)

🌍 International Languages

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

🇱🇰 Local & Regional Language Support

• Sinhala
• Tamil
• English (Sri Lanka regulatory format)

English ↔ Sinhala | English ↔ Tamil | Foreign Language ↔ English / Sinhala / Tamil

All translations are reviewed by regulatory experts experienced with NMRA requirements.

Industries We Serve – Sri Lanka

• Pharmaceuticals & APIs
• Medical Devices
• Vaccines & Biologicals
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Herbal & Traditional Medicines
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Sri Lanka?

✅ Sri Lanka-regulatory-focused translation (not generic translation)
✅ Proven expertise in NMRA documentation
✅ Native-language scientific & regulatory reviewers
✅ Terminology consistency across Sri Lanka submissions
✅ Authority-ready, inspection-friendly documentation
✅ End-to-end support including post-submission regulatory queries
✅ Strict confidentiality & data security

Global & Sri Lanka Regulatory Expertise

Our Sri Lanka services support:

• NMRA product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Export-support translations for South Asia & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject an NMRA approval in Sri Lanka.

That’s why we deliver precision-driven, regulator-acceptable translations, fully aligned with Sri Lankan compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Sri Lanka

If you want next, I can:
✔ Prepare SEO-optimized Sri Lanka landing page content
✔ Create Sinhala–Tamil–English trilingual brochures
✔ Develop NMRA-only pharma / food / cosmetics versions
✔ Convert this for India, Bangladesh, Nepal, ASEAN, GCC, Africa, or LATAM