DossierTrans

Peru 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 Peru-specific dossiers and technical documents, fully aligned with Peruvian pharmaceutical and technical regulatory requirements and Andean Community (CAN) guidelines.

We support manufacturers, marketing authorization holders, importers, exporters, distributors, and regulatory consultants targeting Peru with precise, technically accurate, and authority-acceptable translations, ensuring smooth registrations, evaluations, inspections, and approvals in Peru.

Who We Are

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

All translations are performed and reviewed by subject-matter experts and regulatory professionals experienced with Peru and Andean regulations—not general translators.

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with General Directorate of Medicines, Supplies and Drugs (DIGEMID) expectations

Peru Regulatory Alignment

Our services are aligned with the requirements of:

• General Directorate of Medicines, Supplies and Drugs (DIGEMID)
• Ministry of Health (Ministerio de Salud – MINSA), Peru
• Andean Community (CAN) pharmaceutical regulatory framework
• Peruvian Pharmacopoeia & recognized international references
• Peru Customs & Import–Export Authorities

Our Core Services – Peru

📘 Dossier & Technical Document Translation

• Peru-specific national and CAN-aligned dossier formats
• Administrative, quality, non-clinical & clinical document translations for DIGEMID submissions
• Product information, PILs, labeling & packaging text (Spanish–Peru compliant)
• Stability, validation, bioequivalence & clinical study reports
• SOPs, specifications, COAs, SDS & technical files
• Import registration, marketing authorization, GMP & licensing documentation

🔍 Review of Translated Dossiers

• Scientific and regulatory review of translated documents
• Cross-verification against source (English) dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with DIGEMID guidelines, CAN standards, USP / BP / Ph. Eur. references

🛡️ Post-Submission Regulatory Query Handling – Peru

• DIGEMID deficiency letters and regulatory queries related to translated content
• Scientific clarification and Peru-compliant regulatory re-wording
• Revised translations based on technical assessment reports
• Coordination with local MA holders, importers, and regulatory agents

Languages We Support (Peru-Focused)

We provide professional, native-level regulatory translations relevant to Peru registrations:

🌍 International Languages

• English
• German
• French
• Italian
• Portuguese

🇵🇪 Peru Regulatory Language

• Spanish (Peru) – mandatory for all national submissions, labeling & PILs
• Quechua – where required for public-use information

English ↔ Spanish (Peru) | EU Language ↔ Spanish

All translations are reviewed by scientific and regulatory experts familiar with Peruvian pharmaceutical legislation.

Industries We Serve – Peru

• Pharmaceuticals & APIs
• Medical Devices & Diagnostics
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicinal Products
• Food Supplements & Nutraceuticals
• Chemicals & Biocides
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Peru?

✅ Peru-regulatory-focused translation (not generic translation)
✅ Expertise in DIGEMID & CAN documentation
✅ Native Peruvian Spanish scientific reviewers
✅ Terminology consistency across submissions
✅ Authority-ready, inspection-acceptable documentation
✅ Lifecycle support: variations, renewals & post-approval changes
✅ Strict confidentiality & data security

Global & Peru Regulatory Expertise

Our Peru services support:

• National marketing authorization dossiers
• CAN-aligned registration pathways
• Import & export regulatory documentation
• Post-approval variations, renewals & compliance updates

Our Commitment

At DossierTrans, we understand that even a single mistranslated statement can delay or jeopardize a DIGEMID approval in Peru.

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

DossierTrans – Translating Science into Regulatory Approval in Peru

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