Regulatory Translation & Compliance — Submissions, Labeling, Audit Responses

We translate & localize regulatory submissions, labeling/IFUs, vigilance & PMS, and audit responses. SME review, termbase, in-context LQA, evidence pack, secure delivery.

clinical_notesSubmissions
vaccinesLabeling & IFU
health_and_safetyVigilance
ruleAudit
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Links: ISO 17100 · ISO 27001 · Secure Delivery

Regulatory document sets — translation

task_alt What we translate (at a glance)

  • Submissions: cover letters, forms, core dossiers, responses to questions.
  • Labeling & IFUs: packs, inserts, cartons; dosage & warnings aligned to locale.
  • Vigilance / PMS / PMCF: incident reports, patient-facing docs, summaries.
  • Audit & CAPA: audit responses, SOPs, training records, corrective actions.
  • Quality records: COA, batch docs, validation reports, change controls.
library_books Termbase rule LQA sync_saved_locally Versioning inventory_2 Evidence Pack
Forms & templates — translation

integration_instructions Formats & fidelity

  • We preserve: numbering, footnotes, tables, symbols, units, decimal styles.
  • Files we handle: DOCX/PDF, IDML/INDD, XML/JSON/XLIFF, spreadsheets.
  • In-image text: vector redraws for stamps/seals/diagrams; clear “translation of original” tags.
  • RTL & scripts: Arabic, Devanagari, etc. checked in context for breaks & punctuation.
  • Delivery: multilingual bundles with checksums + delivery receipt.
Label checks — translation & localization

fact_check Controls that regulators expect

  • ISO 17100 / 27001: certified process & information security.
  • Reviewer matrix: linguist → independent reviewer → SME, as needed.
  • QA rules: numbers, ranges, units, warnings; style guide enforcement.
  • Termbase: seeds from labels/SmPC/PL/legacy; “do-not-translate” flags.
  • Evidence pack: SoA, decisions, defect logs, release ledger.
Work with RA/QA teams — translation

groups Working style & outcomes

  • Fast loops: Expedited option for health-authority questions.
  • Clarity: plain-language patient content; consistent warnings & icons.
  • No surprises: change logs + redlines → quick sign-off.
  • Acceptance: we stay on call until the document is lodged & accepted.

Industry Spectrum

Pharma Medical Devices Biotech Food & Nutrition Cosmetics Chemicals Hospital & Clinics Diagnostics Public Health

Document Rack — What we translate

Core dossier translation

Core Dossiers

Modules, summaries, annexes.

Labeling translation

Labeling / IFUs

Inserts, cartons, packs.

Safety warnings translation

Warnings

Symbols, icons, statements.

Vigilance/PSUR translation

Vigilance / PMS

Incidents, summaries.

Audit response translation

Audit & CAPA

Responses, evidence.

Quality records translation

Quality

COA, batch docs, validation.

Reg Path — From intake to authority acceptance

1

flag Intake & Risk

Jurisdictions, timelines, templates, authority expectations.

Regulatory intake
2

fact_check Prep & Termbase

Style guide; termbase; do-not-translate; units & decimals.

Termbase & style guide
3

done_all Translate & Review

Translator → reviewer → SME; citations verified.

Review & SME
4

rule LQA & Build

In-context checks; table rebuilds; RTL; label proofs.

Label proofs
5

inventory Release & Evidence

Multilingual bundle; checksums; release ledger; SoA.

Release kit
6

verified Authority Acceptance

On-call until accepted; quick fixes, if requested.

Acceptance

Evidence Wall — Controls built in

verified

ISO 17100 / 27001

Certified translation process & information security.

library_books

Style Guide & Termbase

Governed terms; do-not-translate; reuse across updates.

rule

QA Rules

Numbers, units, warnings, casing; defect taxonomy.

sync_saved_locally

Versioning

Baselines, diffs, reviewer matrix; change logs.

encrypted

Secure Delivery

Portal/SFTP; checksums; restricted access.

inventory_2

Evidence Pack

SoA, decisions, defect logs, delivery receipts.

schedule Standard
  • Translator + independent reviewer
  • Termbase & style guide; standard LQA
  • Release kit & evidence basics
bolt Expedited
  • Parallel linguists; time-boxed reviews
  • Fast label proofs; prioritized fixes
  • For authority questions/urgent updates
health_and_safety Regulated-Validated
  • SME review; back-translation if required
  • Structured bundles (IDML/INDD, XML, XLIFF)
  • In-context LQA on target proofs/devices
Labeling translation case — 8 locales

vaccines Labeling Set — 8 locales

IFUs + cartons + packs translated; icon harmonization; accepted by authority.

Read case

Audit response translation case

rule Audit Response — CAPA

Defect taxonomy + evidence pack; closed without rework.

Read case

PMS/PMCF translated summaries

clinical_notes PMS / PMCF

Patient-facing summaries translated clearly; SME-checked.

Read case

FAQ — Regulatory Translation

description What formats do you accept?
DOCX, PDF, IDML/INDD, XML/JSON/XLIFF, spreadsheets; tables rebuilt; label proofs generated.
rule How do you ensure accuracy?
Reviewer matrix, QA rules for units/ranges/warnings, termbase, change logs, SoA; SME review if needed.
public RTL & scripts?
Arabic & other scripts verified in context; punctuation, line breaks, directionality checked.
lock Confidentiality?
NDA, restricted access, optional watermark previews; secure portal/SFTP delivery with checksums.
bolt Urgent authority questions?
Use Expedited: parallel linguists, fast proofs, prioritized fixes; we stay on call until accepted.
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Secure delivery (TLS/SFTP) • ISO 17100 • ISO 27001 • NDA by default