Term drift across a dossier
The same concept worded three ways in three modules. Reviewers cannot assume they are the same thing, so they ask — and the clock restarts. A locked glossary agreed before translation begins is the whole defence.
Industry
When a filing comes back, it is rarely the science.
Regulatory submissions fail on language more often than anyone likes to admit: a term rendered two ways across a dossier, an annex left in the original, a version that no longer matches the one under review. This is the work of preventing that.
Pharmaceutical & Healthcare
What we support
STIB translates and interprets for pharmaceutical, medical device and healthcare organisations working between Brazil and the rest of the world — regulatory documentation, clinical and scientific material, and the audits and inspections where a regulator is in the room.
The defining constraint in this sector is not fluency, it is consistency. A registration dossier can run to thousands of pages assembled by different teams over months. If the same active ingredient, the same indication or the same manufacturing step is worded differently in three places, a reviewer has to decide whether those are three things or one — and that question is what sends a filing back.
What we translate and interpret
- Regulatory registration dossiers — the core submission, where terminology has to hold across every module and annex
- Clinical trial protocols and informed consent forms — consent has to be genuinely understandable in the patient's language, not a literal rendering of the English
- GMP audit documentation — procedures, deviations and CAPA records read by auditors who did not write them
- Package inserts (bulas) and labeling — format and wording are prescribed, so translation is constrained by the template as well as the meaning
- Pharmacovigilance reports — adverse event narratives, where a softened verb changes the clinical picture
- Medical device technical files — instructions for use, risk files and conformity documentation
Failure modes
Where language actually fails in this sector
Not theory — these are the recurring ways a language workstream costs a project time.
Annexes nobody translated
The main body is submitted in the target language and the annexes are not, because they were treated as attachments rather than content. This is one of the most common avoidable rejections.
Version drift
The document translated was not the version filed. When a submission is revised late, the translation memory has to be revised with it.
Live settings
Where we interpret in this sector
Regulatory inspections and audits
Consecutive or whispered interpreting while inspectors move through a facility — the interpreter has to handle the procedural register and the shop-floor register in the same hour.
Investigator meetings
Simultaneous interpreting for multi-site clinical meetings, usually with two interpreters per language for sessions over an hour.
Health authority meetings
Pre-submission and clarification meetings, where precision about what was and was not claimed matters more than fluency.
Regulatory context
Bodies and frameworks in play
Documentation and interpreting in this sector regularly involve requirements and terminology tied to the following bodies. We match linguists who have worked with the relevant framework, rather than treating them as generic technical text.
ANVISA
Brazil's health regulatory agency, responsible for registering and supervising medicines, medical devices and food.
FDA
The United States Food and Drug Administration — the counterpart authority in most Brazil–US filings.
INMETRO
Brazil's metrology, standardisation and conformity assessment body, relevant to device certification.
CFM
Conselho Federal de Medicina, the federal medical council whose resolutions shape clinical practice documentation.
COFEN
Conselho Federal de Enfermagem, the federal nursing council, relevant to nursing protocols and records.
Straight answers
Pharmaceutical & Healthcare: questions we are asked
Do you translate ANVISA registration dossiers?
Yes. STIB translates regulatory registration dossiers and their annexes, working from an agreed glossary so that terminology stays identical across every module. Whether a specific document needs a particular form of certification depends on the submission, and we will say so before starting rather than after.
How do you keep terminology consistent across a large submission?
A glossary of defined terms, product names and process steps is built from the source documents and agreed with your regulatory team before translation begins. Every linguist on the project works from it, and it is reused when the dossier is revised, so a late change does not reintroduce inconsistency.
Can you provide interpreters for a GMP audit or inspection?
Yes. Facility audits and inspections are usually covered with consecutive or whispered interpreting, because the group moves through the site rather than sitting. Interpreters are assigned under a confidentiality agreement and briefed on the procedures and vocabulary in advance.
Is a certified translation required for clinical documentation?
It depends on the document and the authority receiving it. STIB provides certified and professional translation; it does not currently offer legally sworn translation (Tradução Juramentada) in Brazil. Tell us which body the document is going to and we will advise on what that body requires.
How is confidential clinical material handled?
Under a non-disclosure agreement signed before any file is shared, with named linguists assigned to the project and material circulated only to the people working on it. STIB signs the client's own NDA when required.
Tell us what is on the table.
The documents, the meeting, the dates and the languages. You get a scoped proposal from the team that will run the assignment.