Regulatory & clinical documentation services
Regulatory & Clinical Documentation in English from Spanish and Portuguese
For biotech companies, CROs, and pharmaceutical and medical / dental device companies in Spain, Portugal and Latin America
Linguistic error in regulatory & clinical documentation is rarely isolated. It tends to be structural. It surfaces late in the regulatory submission workflow and propagates across document sets.
Inconsistent terminology, inaccurate nomenclature, and misalignment between regulatory regions lead to rejected submissions, rework, and delays that cost more time and money before these submissions are suitable for scrutiny by the EMA, FDA, COFEPRIS, ANVISA and other regulatory authorities.
BioLingua Life Sciences combines both clinical and linguistic expertise to identify and control these risk points at their source, before they spread.
The result is clear, accurate and consistent English for regulatory, clinical and scientific teams working in Spanish- and Portuguese-speaking countries.
BioLingua Life Sciences was established by a healthcare professional and certified translator who has extensive experience working with global CROs, pharma and biotech companies, and major insurance groups through leading LSPs.
Our other senior linguists also combine formal translation qualifications with clinical backgrounds.
AI can facilitate the work, but it cannot be held accountable for error. That is why human oversight is not an optional step; it is the final and non-negotiable stage of every BioLingua workflow.
Who We Are
Services
For teams where documentation quality is non-negotiable
Regulatory Documentation Translation
Accuracy, consistency and alignment across document sets and regulatory regions. Terminology management included as standard.
- Clinical trial protocols
- Investigator’s Brochures
- SmPCs (Summary of Product Characteristics)
- Package leaflets
- Regulatory correspondence
Clinical Documentation
Translation
Specialist and patient-facing materials handled with correct clinical terminology and appropriate register – adult, minor or specialist – across all document types.
- ICF — Informed Consent Forms
- CRF — Case Report Forms
- Patient-facing materials
- Clinical Study Reports
Independent Quality
Assurance (QA) Review
The primary entry point for most of our clients.
Structured review of existing translations to identify terminology errors, inconsistencies, conceptual drift and register errors produced by third-party providers.
Lingustic Validation - PREMIUM SERVICE
Regulatory agencies — including the EMA, FDA and MHRA — require rigorous linguistic validation for Patient-Reported Outcomes (PRO) and Clinical Outcome Assessments (COA) used in multinational trials. Conceptual drift in these instruments doesn’t just affect readability — it can compromise data integrity and put trial endpoints at risk.
BioLingua’s Linguistic Validation service follows the ISPOR methodology:
Independent back-translation performed by a linguist blind to the original source, systematically compared against the reconciled translation to verify conceptual and linguistic equivalence. Discrepancies are documented and resolved before finalization.
(PRO and COA questionnaires, patient diaries, informed consent forms, and other regulatory-sensitive instruments requiring formal equivalence verification.)
Scope &
Risk Review
Terminology &
Reference Alignment
Translation or Independent QA
Final Review &
Query Log
Approach
Scope & Risk Review
Project scope, document function and risk points are defined upfront. Document type, subject matter and submission context are confirmed before any work begins.
Terminology & Reference Alignment
Key terminology, reference materials, and client style guides and preferences are aligned before work begins. A project-specific glossary is established and applied consistently throughout.
Translation or Independent QA
Translation is carried out by a clinician-translator with subject-matter expertise in the relevant document type. For Independent QA, a linguist independent of the original translation reviews the document against the source for accuracy, consistency and register.
Final Review & Query Log
Every deliverable is personally reviewed and signed off by a senior clinician-translator. All queries and key decisions are documented and assigned to a named reviewer. Nothing is released without explicit human sign-off.
Use of AI &
Confidentiality
AI assists in the draft stage only.
Every deliverable is reviewed, edited and approved by a qualified clinician-translator.
Client data is handled exclusively within secure, closed systems.
All engagements are governed by confidentiality agreements compliant with GDPR standards.
Request a Document Review
Let us know about your project by filling out our contact form below.
If you are facing an immediate regulatory submission deadline or need an urgent dossier audit, email us directly at admin@biolingualifesciences.com for accelerated triage.
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All rights reserved.
admin@biolingualifesciences.com
Spain · Portugal · Latin America