DossierTrans – Philippines

Philippines 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 Philippines-specific dossiers and technical documents, aligned with Philippine regulatory authorities and statutory requirements.

We support Philippine 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 the Philippines.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Philippine 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 Philippines-specific FDA / DOH expectations

Philippines Regulatory Alignment

Our services are aligned with the requirements of:

• Food and Drug Administration (FDA), Philippines
• Department of Health (DOH), Republic of the Philippines
• Center for Drug Regulation and Research (CDRR)
• Center for Food Regulation and Research (CFRR)
• Center for Cosmetics Regulation and Research (CCRR)
• ASEAN Harmonized Technical Requirements (ACTD / ACTR)
• Bureau of Customs (BOC), Philippines
• Other applicable import & export regulatory authorities in the Philippines

Our Core Services – Philippines

📘 Dossier & Technical Document Translation

• Philippines-specific ACTD / non-ACTD dossier formats
• Administrative & technical dossier translations for Philippine FDA submissions
• Labels, package inserts, leaflets & artwork text (English / Filipino compliant, as required)
• 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 Philippine FDA guidelines, ACTD references, and DOH requirements

🛡️ Post-Submission Regulatory Query Handling – Philippines

• Philippine FDA / DOH 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 (Philippines-Focused)

🌍 International Languages

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

🇵🇭 Local & Regional Language Support

• English (primary regulatory language)
• Filipino (Tagalog) – where required for labels / consumer-facing text

English ↔ Filipino | Foreign Language ↔ English / Filipino

All translations are reviewed by regulatory experts experienced with Philippine FDA and ASEAN submission requirements.

Industries We Serve – Philippines

• 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 the Philippines?

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

Global & Philippines Regulatory Expertise

Our Philippines services support:

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

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a Philippine FDA approval.

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

DossierTrans – Translating Science into Regulatory Approval in the Philippines

If you want next, I can:
✔ Prepare SEO-optimized Philippines landing page content
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✔ Develop FDA-only pharma / food / cosmetics versions
✔ Convert this for Thailand, Vietnam, Malaysia, GCC, Africa, or LATAM