DossierTrans – Kenya

Kenya 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 Kenya-specific dossiers and technical documents, aligned with Kenyan regulatory authorities and statutory requirements.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Kenyan 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 Kenya-specific PPB / MoH expectations

Kenya Regulatory Alignment

Our services are aligned with the requirements of:

• Pharmacy and Poisons Board (PPB), Kenya
• Ministry of Health (MoH), Republic of Kenya
• Pharmacy and Poisons Act (Cap 244)
• PPB Guidelines for Registration of Medicines & Medical Devices
• WHO prequalification & reliance pathways (where applicable)
• Kenya Bureau of Standards (KEBS)
• Kenya Revenue Authority (KRA) – Customs Services
• Other applicable import & export regulatory authorities in Kenya

Our Core Services – Kenya

📘 Dossier & Technical Document Translation

• Kenya-specific CTD / non-CTD dossier formats
• Module 1–5 translations for PPB submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (English-compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, import permit & 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 PPB guidelines, MoH requirements, and accepted pharmacopoeias (USP, BP, EP)

🛡️ Post-Submission Regulatory Query Handling – Kenya

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

Languages We Support (Kenya-Focused)

🌍 International Languages

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

🇰🇪 Local & Regional Language Support

• English (official regulatory language)
• Swahili – where required for public-facing, donor, or NGO documentation

English ↔ Swahili | Foreign Language ↔ English / Swahili

All translations are reviewed by regulatory experts experienced with PPB Kenya requirements.

Industries We Serve – Kenya

• 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 Kenya?

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

Global & Kenya Regulatory Expertise

Our Kenya services support:

• PPB product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Import permit & customs documentation
• Export-support translations for EAC, East Africa & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a PPB approval in Kenya.

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

DossierTrans – Translating Science into Regulatory Approval in Kenya

If you’d like next, I can:
✔ Prepare SEO-optimized Kenya landing page content
✔ Create English–Swahili bilingual brochures
✔ Develop PPB-only pharma / medical device / food versions
✔ Convert this for Uganda, Tanzania, Rwanda, EAC, Africa, or LATAM