SPECIALIZED SERVICE · Español ↔ Inglés
Linguistic Quality Control for Regulatory Submissionsregulatorios
We review and harmonize regulatory terminology in Spanish and English to ensure consistency, accuracy, and uniformity across the entire regulatory dossier.
+20 years of experience
Biomedicine · Pharma
EMA · FDA · GCP
Official Sworn Translator
What Does Linguistic Quality Control Involve?
This service reviews and validates the terminology used in regulatory documentation in Spanish and English, aligning it with the official guidelines and glossaries of regulatory agencies and ensuring that each term is used consistently across the entire dossier.
A regulatory dossier is not a single document. It is a set of documents — protocols, reports, procedures, technical information — that all need to speak exactly the same technical language.
What Does the Service Include?
- Regulatory dossiers (CTDs): linguistic review and quality control of Common Technical Document modules before submission to regulatory agencies. Alignment with regulatory terminology (EMA, FDA, ICH, GxP): verification and adaptation of terminology in accordance with the official guidelines, glossaries, and regulatory frameworks of leading international agencies. Terminological consistency across dossier documents (SOPs, protocols, CSR, IB): identification and correction of inconsistencies between standard operating procedures, trial protocols, clinical study reports (CSRs), and investigator’s brochures (IBs). Terminological accuracy in CAPAs: review of corrective and preventive actions to ensure terminology is accurate, traceable, and consistent throughout the dossier. Support for GCP/GMP audits and inspections: linguistic and terminological quality control of documentation submitted during Good Clinical Practice and Good Manufacturing Practice audits and inspections.
Who Is This Service For?
Designed for organizations that need to demonstrate terminological consistency and accuracy to regulatory agencies, auditors, and inspectors.
Pharmaceutical & Biotech
- Pharmaceutical laboratories
- Biotechnology companies and healthcare start-ups
- Regulatory Affairs departments
Clinical Research
- CROs (Contract Research Organizations)
- Clinical trial units
- Biomedical research foundations and institutes
- Hospitals with research departments
Regulatory Affairs
- Regulatory consulting firms (EMA, FDA, AEMPS)
- Regulatory Affairs specialists
- Biomedical research foundations and institutes
GCP/GMP Audits & Inspections
- Quality control units and managers
- Quality Assurance teams in clinical trials and manufacturing
- CAPA managers
Reviews & Testimonials from Those Who Already Trust Us
Translated Scientific Articles
Translated Clinical Reports
Years of Specialized Experience
Your Partner with 20 Years of Biomedical Expertise
Nuria Hernández Buendía is not a generalist agency. She is a specialist with over 20 years of exclusive experience in biomedicine, clinical trials, and pharmacology, with a deep understanding of the cultural nuances that set audiences apart and the language that patients and the general public can understand.
- 1,000+ scientific articles translated and published in high-impact international journals
- 20+ years of exclusive specialization in biomedicine, clinical trials, and pharmacology
- In-depth knowledge of EMA, FDA, ICH, GCP, and Horizon Europe regulations
- Official sworn translator: one partner for all your scientific, legal, and academic translation needs
- Genuine cultural adaptation, not just linguistic adaptation — incorporating local references and patient context
- 100% personalized and confidential service, with no mass automated platforms
Only 3 Steps to Receive Your Document Ready for Publication
Request a Quote
Use the web form, email info@traductorcientificos.es, or send a WhatsApp message to +34 687 988 096. You’ll receive a response within 24 hours4 h.
Send Your Document
Once the quote has been approved, share your file in whatever format you have (Word, PDF, Excel, etc.). Confidentiality is guaranteed from the very beginning.
Receive Your Document Ready for Publication
Delivery with validated terminology, cultural adaptation, and consistency review included. An additional round of revisions is also available.
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proyectos@traductorescientificos.es
Teléfono y Whatsapp
+34 687 98 80 96