Ensure linguistic precision and regulatory compliance across borders. At Althian, we offer certified translation and localization services for regulatory documents, tailored to meet the specific requirements of health authorities in Mexico, Brazil, Colombia, and other Latin American markets. Our team of bilingual experts ensures that every document—whether for clinical trials, product registration, pharmacovigilance, or labeling—is accurately translated and culturally adapted to comply with local language standards and regulatory expectations.

Certified Regulatory Translations

• Translation of technical and regulatory documents including protocols, investigator brochures, informed consent forms, PSURs, RMPs, and labeling materials.

• Certified translations accepted by COFEPRIS, ANVISA, INVIMA, DIGEMID, and other LATAM health authorities.

• Linguistic accuracy combined with regulatory terminology to ensure clarity and compliance.

Localization for Regional Compliance

• Adaptation of content to reflect country-specific regulatory language, cultural nuances, and formatting standards.

• Review of translated materials to align with local expectations for tone, structure, and legal phrasing.

• Support for bilingual submissions and packaging in Spanish–English or Portuguese–English formats.

Document Formatting & Submission Readiness

• Formatting translated documents for inclusion in CTD/eCTD dossiers and electronic submissions.

• Integration of translated content into regulatory templates, ensuring consistency across modules.

• Quality control and version tracking to maintain audit readiness and submission integrity.

Subject-Matter Expertise

• Translators with deep knowledge of clinical research, regulatory affairs, and medical terminology.

• Collaboration with Althian’s regulatory consultants to ensure alignment with submission strategy and agency expectations.

• Specialized support for high-impact therapeutic areas including oncology, infectious diseases, CNS, and rare diseases.