Accuracy and sign-off, built into the workflow.
Multilingual content for pharma, medical communications, devices and regulated industries. Qualified linguists, ISO-aligned process, MLR-ready delivery — every brief, every market.
Teams we work with, and the work we take on.
Audience-first — the teams that brief us, and the work each of them tends to bring.
Regulatory & medical affairs
Submissions support, label and SmPC adaptation, periodic safety updates — handled by linguists with prior pharma file ownership.
Clinical operations
Protocol, ICF, PRO and clinician-rated instrument translation with ISPOR-aligned forward / back / reconciliation workflows.
MedComms & medical writing agencies
White-label adaptation of congress decks, advisory board materials and KOL content — keyed into your house glossary and reviewer cadence.
Medical device & diagnostics
IFU, labelling and UI strings localised against MDR / IVDR market requirements, with notified-body documentation supported.
- HCP and patient-facing comms
- Regulatory submissions support
- Internal training and SOP localisation
- Clinical content adaptation
- Medical device documentation
- Multilingual congress assets
Three things regulated work needs.
Compliance-aware workflows
Process and review designed around regulatory sign-off, with the right gates in the right places.
Qualified specialist linguists
Native, in-market specialists with documented sector experience — assigned per brief, not per queue.
Audit-ready delivery
Versioning, traceability and QA records produced on request, in the format reviewers expect.
Four stages, one closing band of numbers.
- 01
Scope against the frame
EMA, MHRA, FDA, MDR / IVDR — the relevant frame is agreed at kickoff so the workflow, qualifications and QA gates are right from day one.
- 02
Qualified linguist assignment
Native, in-market, sector-qualified. Documented experience in the relevant therapy area or device class, not a generic medical pool.
- 03
Validation workflow
Forward translation, independent back-translation, reconciliation, harmonisation and proofreading — versioned, with a reconciliation report supplied where applicable.
- 04
MLR-ready handover
Files delivered in the format reviewers expect, with glossary updates, change log and audit-trail documentation so sign-off doesn't bounce.
Sourcing, qualification and revision steps aligned to the ISO 17100 standard for translation services, with records to match.
Forward translation, independent back-translation and reconciliation as the default for clinical and PRO instruments.
Every linguist, every revision, every sign-off captured. Supplied on request in the format your reviewers ask for.
For regulatory, medical and clinical teams.
EMA, MHRA, FDA-aligned and ICH guidance for clinical and medical communications, with country-level adaptation across European, UK and major global markets. Briefs are scoped against the relevant frame at kickoff.
Yes — independent back-translation by a separate native linguist, with reconciliation reports for clinical, PRO and IFU work where regulators expect it.
Source review, forward translation, independent back-translation, reconciliation, harmonisation and proofreading — fully versioned and traceable, aligned to ISPOR good practice.
Yes. Output is delivered in formats and with documentation that medical, legal and regulatory reviewers can sign off without rework — terminology controlled, references resolved, change log included.
Per-client glossaries and translation memories maintained across projects, with terminology validated by sector-qualified linguists before it enters the asset.
Yes — every step, every linguist, every change is logged. We can supply audit-ready documentation on request, including QC sign-off and version history.
Services pharma briefs usually run with.
Localisation
Clinical, regulatory and patient-facing content adapted with the review layers regulated work demands.
Transcreation
For unbranded and DTC creative that still has to clear MLR — handled by linguists who know the rules of the room.
AI voice (AVR)
Validated AI voice for training and internal comms volume — never used in patient-facing or regulated channels without explicit sign-off.