Tier 1-A · Guaranteed first-review acceptance
Dossier-critical translation with a financial guarantee behind every page.
Tier 1-A is built for submissions where a translation-grounds rejection blocks a launch window. You get the full Six-Gate QC workflow, a dedicated regulatory review memo, and a $2,500/business-day delay credit if a first-review rejection is attributable to translation.
Price
$0.30–0.38 / word
$120–150 per page (250 words). per source word / per 250-word regulatory page.
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
- Regulatory review memo naming applicable resolution / disposição / NOM
- 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
- White-glove submission support with your regulatory affairs team
Turnaround
Timelines you can commit to internally
- Standard turnaround (≤10K words)
- 3–5 business days
- Rush turnaround (≤10K words)
- 48 hours
- Large batches (10K–50K words)
- Scoped delivery plan with weekly milestones
- Re-issue SLA if translation-grounds rejection
- 48 hours
Timelines are calendar business days from batch confirmation and cover the certified deliverable, not source hand-off delays.
Scope
What Tier 1-A covers
- Regulatory dossiers: CTD Modules 1–5, Common Technical Document annexes, protocol synopses
- Investigator brochures, IB updates, addenda
- Informed consent forms + subject-facing material for ethics committees
- Manufacturing dossiers: CPP, CBPF / GMP certificates, master file summaries
- Any submission where a first-review rejection would block a launch or enrollment window
First-Pass Acceptance Program
Guarantee terms
- $2,500 credit per business day of delay if a first-review rejection is attributable to translation.
- Re-issue within 48 hours at no additional cost when a rejection is on translation grounds.
- Credit applies against the current batch or the next Tier 1-A engagement, at your election.
- Financial delay credit is exclusive to Tier 1-A; Tier 1-B still includes re-issue at no cost.
Comparing to Tier 1-B?
See the full scope, deliverables, and SLA for Tier 1-B.
Ready to scope a Tier 1-A batch?
Share your countries, program type, and target submission window. We reply within 2 business days with a fixed quote and delivery plan.