01
Industry specialisation
Pharma, API and medical-device quality work — not general-purpose translation.
Pharmaceutical linguistic support
Linguistic support for pharmaceutical inspections and audits
Precise, industry-fluent interpretation for GMP inspections, pharmaceutical audits and ISO 13485 assessments.
NDA-ready workflowIndustry specialistsWorldwide coordination
Inspection preparation
QA
Shared terminologyGlossary aligned before the opening meeting
On site
GxP
Live supportExact dialogue, retained context
Core services
Specialist support for regulated quality work
Each direction combines linguistic skill with preparation for a specific audit environment.
01
GMP Inspections
End-to-end linguistic preparation and on-site interpreting for regulated pharmaceutical inspections.
Explore service →02
Pharmaceutical Audits
Clear communication across supplier, CMO/CDMO, qualification and partner audits.
Explore service →03
ISO 13485 Audits
Specialist interpreting for certification, surveillance and supplier audits of medical-device quality systems.
Explore service →GMPregulated inspection focus
3core audit services
NDAconfidential workflow
Globalspecialist network model
Why GxP Translation
Four controls around every assignment
02
Structured preparation
Every assignment starts with scope analysis, glossary build and approved document review.
03
Context continuity
Terminology remains aligned across rooms, functions and specialists.
04
Confidential workflow
NDA, controlled document access and client-approved publication rules.
Selected work
How approved project evidence will be presented
These records are illustrative and stay visibly marked until the client approves real case facts.
Illustrative case
EU GMP re-inspection of a sterile injectables plant
Sample outcome: Communication remained consistent across production and QA; the approved glossary was handed over for follow-up.
View case →Illustrative caseMock inspection readiness for a biologics site
Sample outcome: Site teams rehearsed critical quality discussions using one aligned terminology set.
View case →Illustrative caseAPI supplier qualification audit for an EU MAH
Sample outcome: CAPA and qualification terminology remained aligned between the audit and supplier teams.
View case →Trusted by regulated teams
Client identities appear only after written approval
The production CMS contains dedicated logo records and publication controls.
Approved client logo 01
pending approval
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Approved client logo 02
pending approval
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Approved client logo 03
pending approval
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Approved client logo 04
pending approval
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Our specialists
Language skill plus sector experience
Illustrative profiles demonstrate the future content structure, not the published team roster.
Illustrative profile
AB
Dr. Anna Bergmann
- Languages
- DE ↔ EN · FR ↔ EN
- Expertise
- GMP and sterile manufacturing
- Experience
- 14 years
- Location
- Berlin, Germany
EV
Elena Vogt
- Languages
- DE ↔ EN
- Expertise
- IVD and quality systems
- Experience
- 8 years
- Location
- Zurich, Switzerland
LW
Li Wei
- Languages
- ZH ↔ EN
- Expertise
- ISO 13485 and medical devices
- Experience
- 9 years
- Location
- Shanghai, China
How we work
Preparation before interpretation
A six-stage workflow protects context from the first enquiry through the closing meeting.
01
Request analysis
Site, dates, languages and confidentiality requirements.
02
Program and scope
Agenda, roles and terminology areas are mapped.
03
Specialist selection
Language, region and technical experience are matched.
04
Documentation
Approved records and terminology are reviewed.
05
Project glossary
Critical terms are aligned before the event.
06
On-site support
Context is preserved through the closing meeting.
Project enquiry
Discuss the inspection before the agenda is fixed
Share the site, dates, languages and type of assessment. We will review the project context confidentially.
Start an enquiryNDA-ready · Specialist selection · Worldwide coordination