Dossier preparation for submission to LATAM Regulatory Authorities
Save time and ensure regulatory compliance. We are experts in the collection, organization, and format preparation of the required documentation included in the Dossier across Latin America countries.
What does our Dossier Translation Service entail?
Our primary goal is to simplify and expedite the integration of your Dossier for the translation, whether in the generally accepted CTD format, or any other structure required by the Authorities. The process involves several key stages:
- Document Collection: Clients provide their documentation, and we thoroughly assess the necessary formatting, translation, and editing work required to meet local standards.
- Translation: To streamline the entire process, we efficiently assign the translation team to speed the process, ensuring linguistic accuracy and compliance.
- Review & Preparation: Our dedicated team meticulously evaluates, corrects and finally delivers all documentation once all the QA analysis has been executed.
Our main areas of expertise
NabarPharma offers the full process of translation (translation, edition, proofreading), localization and Edition of Machine translation powered with AI.
Translation
Edition
Machine translation powered with AI
Localization
A wide range of documents in the Medical Domain
NabarPharma provides expert translation services for life sciences documents, including clinical trials, regulatory submissions, and patient-facing materials. Our specialized linguistics have the expertise and ensure accuracy and compliance across all document types.
Clinical Outcome Assessment
- Patient Reported Outcome (PRO)
- Observer-reported Outcome (ObsRO)
- Clinician Reported Outcome (ClinRO)
- Performance Reported Outcome (PerfRO/PerfO)
Clinical Trials, Patient-Facing
- Informed Consent Form (ICF)
- Patient Diaries
- Patient Information Leaflets (PIL)/Package Insert/Prescribing information
- Patient Information Sheet (PIS)
Clinical Trials, Physician-Facing
- Case Report Form (CRF)
- Clinical Study Report (CSR)
- Investigator's Brochure (IB)
- Pharmacological Report
- Protocol
Medical Devices
- Instructions for Use (IFU)
- Manuals)
- Software
Regulatory
- Product Leaflets (PLs)
- Summary of Product Characteristics (SmPCs)
- Letters to/from Authorities (NCAs)
Other Life Sciences Content
- Clinical Trial Agreement (CTA)
- Corporate Communication
- Employee E-learning
- Health Insurance/ Member Service / Community Health Communication
- Scientific Article
Clinical Outcome Assessment
- Patient Reported Outcome (PRO)
- Observer-reported Outcome (ObsRO)
- Clinician Reported Outcome (ClinRO)
- Performance Reported Outcome (PerfRO/PerfO)
Clinical Trials, Patient-Facing
- Informed Consent Form (ICF)
- Patient Diaries
- Patient Information Leaflets (PIL)/Package Insert/Prescribing information
- Patient Information Sheet (PIS)
Clinical Trials, Physician-Facing
- Case Report Form (CRF)
- Clinical Study Report (CSR)
- Investigator's Brochure (IB)
- Pharmacological Report
- Protocol
Medical Devices
- Instructions for Use (IFU)
- Manuals
- Software
Regulatory
- Product Leaflets (PLs)
- Summary of Product Characteristics (SmPCs)
- Letters to/from Authorities (NCAs)
Other Life Sciences Content
- Clinical Trial Agreement (CTA)
- Corporate Communication
- Employee E-learning
- Health Insurance/ Member Service / Community Health Communication
- Scientific Article
The key areas of work of our Medical Translation Agency
At NabarPharma, we understand the critical importance of accuracy and clarity in medical and pharmaceutical communication. Our comprehensive range of services is designed to meet the unique demands of the life sciences industry, ensuring your message is conveyed with the highest level of linguistic and scientific precision.
Medical Translation
Our core expertise lies in specialized medical translation. We handle a wide array of documents, from clinical trial protocols and regulatory submissions to pharmaceutical marketing materials and scientific publications. Our linguists are not only native speakers but also possess deep subject matter expertise in various medical fields, ensuring terminological accuracy and contextual relevance.
- Clinical Trial Documentation
- Regulatory Affairs Documents
- Pharmaceutical Marketing
- Scientific Publications
- Patient Information Leaflets
Machine Translation Post-Editing (MTPE) with AI
Leveraging the **últimos avances en Inteligencia Artificial**, nuestros servicios de MTPE ofrecen una solución altamente eficiente y precisa para proyectos de gran volumen. Si bien utilizamos IA de vanguardia para acelerar el proceso de traducción inicial, nuestros experimentados post-editores refinan meticulosamente el resultado generado por la máquina para cumplir con los más altos estándares de calidad humana, adhiriéndose estrictamente a las directrices de ISO 18587. Este enfoque combina la velocidad de la IA con la precisión y el matiz de la experiencia lingüística humana, garantizando una entrega rápida sin comprometer la calidad.
- AI-Enhanced Translation
- Human Quality Assurance
- Faster Turnaround Times
- Cost-Effective Solutions
Desktop Publishing (DTP)
Beyond translation, our Desktop Publishing team ensures your documents are perfectly formatted and ready for publication. We work with a variety of file formats, maintaining the original layout, graphics, and visual integrity across all languages. From complex pharmaceutical dossiers to intricate diagrams, our DTP specialists ensure your translated content looks as professional as it reads.
- Layout and Formatting
- PDF and Image Editing
- Graphic Localization
- Print-Ready Files