DossierTrans

Mexico 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 Mexico-specific dossiers and technical documents, fully aligned with Mexican pharmaceutical and technical regulatory requirements.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Mexican 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 Mexico and LATAM regulations—not general translators.

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Federal Commission for the Protection against Sanitary Risks (COFEPRIS) expectations

Mexico Regulatory Alignment

Our services are aligned with the requirements of:

• Federal Commission for the Protection against Sanitary Risks (COFEPRIS)
• Ministry of Health (Secretaría de Salud), Mexico
• General Health Law (Ley General de Salud) & applicable NOMs
• Pharmacopoeia of the United Mexican States (FEUM)
• PAHO / WHO-aligned regulatory guidance
• Mexico Customs & Import–Export Authorities

Our Core Services – Mexico

📘 Dossier & Technical Document Translation

• Mexico-specific national dossier formats
• Administrative, quality, non-clinical & clinical document translations for COFEPRIS submissions
• SmPC, patient information leaflets, labeling & packaging text (Spanish–Mexico compliant)
• Stability, validation, bioequivalence & clinical study reports
• SOPs, specifications, COAs, SDS & technical files
• Sanitary registration, variations, renewals, 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 COFEPRIS guidelines, NOMs, FEUM, USP / BP / Ph. Eur. references

🛡️ Post-Submission Regulatory Query Handling – Mexico

• COFEPRIS deficiency letters and regulatory queries related to translated content
• Scientific clarification and Mexico-compliant regulatory re-wording
• Revised translations based on technical and legal assessment comments
• Coordination with local MA holders, importers, CROs, and regulatory agents

Languages We Support (Mexico-Focused)

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

🌍 International Languages

• English
• German
• French
• Italian
• Portuguese
• Chinese

🇲🇽 Mexico Regulatory Language

• Spanish (Mexico) – mandatory for all national submissions, labeling & PILs

English ↔ Spanish (Mexico) | EU Language ↔ Spanish

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

Industries We Serve – Mexico

• Pharmaceuticals & APIs
• Medical Devices & IVDs
• Biologics, Vaccines & Biosimilars
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicinal Products
• Food Supplements & Nutraceuticals
• Chemicals & Disinfectants

Why Choose DossierTrans for Mexico?

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

Global & Mexico Regulatory Expertise

Our Mexico services support:

• National sanitary registration dossiers
• Import & export regulatory documentation
• Clinical research & bioequivalence support documentation
• Post-approval variations, renewals & compliance updates

Our Commitment

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

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

DossierTrans – Translating Science into Regulatory Approval in Mexico

If you want next, I can:
✔ Create Brazil, Colombia, Chile, or full LATAM versions
✔ Convert this into SEO-optimized landing-page format
✔ Prepare brochure, proposal, or pitch-deck versions