Tier 1-B · Standard regulatory translation

Full Six-Gate QC and audit trail — priced for high-volume clinical and MedTech content.

Tier 1-B carries the same Six-Gate QC, signed certificate, and adversarial back-translation as Tier 1-A. You get standard re-issue at no cost if a first-review rejection is attributable to translation. It's the right fit when a submission is a re-file, a MedTech IFU, or a batch that isn't gating a launch window.

Price

$0.19–0.24 / word

$75–95 per page (250 words). per source word / per 250-word regulatory page.

Request a Tier 1-B quote →Get the rate card

Deliverables

What lands in your inbox

  • Signed certificate of accuracy on regulator-ready letterhead
  • Certified PDF + editable source (DOCX / IDML / XLIFF)
  • Adversarial back-translation with reviewer commentary
  • Jurisdiction-ready formatting (ANVISA, COFEPRIS, INVIMA, ANMAT, ISP, DIGEMID, ARCSA, MINSA)
  • Translation memory + terminology glossary handed back with the batch
  • Complete audit ZIP: translator credentials, QC gates, revision history

Turnaround

Timelines you can commit to internally

Standard turnaround (≤10K words)
5–7 business days
Rush turnaround (≤10K words)
72 hours
Large batches (10K–50K words)
Scoped delivery plan with weekly milestones
Re-issue SLA if translation-grounds rejection
5 business days

Timelines are calendar business days from batch confirmation and cover the certified deliverable, not source hand-off delays.

Scope

What Tier 1-B covers

  • Clinical study reports, statistical analyses, safety narratives
  • MedTech instructions for use (IFU), labeling, and technical files
  • Investigator-facing training material, site correspondence, and monitoring visit reports
  • Re-submissions of previously accepted dossiers with minor updates
  • High-volume localization for post-market surveillance or PSUR content

Standard SLA

Standard SLA

  • Re-issue at no additional cost within 5 business days if a first-review rejection is attributable to translation.
  • Financial delay credit is not included in Tier 1-B — that is exclusive to Tier 1-A.
  • A batch can be upgraded to Tier 1-A before the final certification step; the Tier 1-A guarantee applies from that point forward.

Need the guarantee?

See the full scope, deliverables, and SLA for Tier 1-A.

View Tier 1-A →

Ready to scope a Tier 1-B batch?

Share your countries, program type, and target submission window. We reply within 2 business days with a fixed quote and delivery plan.

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