Platform — Regulatory Language Infrastructure™
Six-step pipeline · Twelve regulators · One signed certificate per file
A six-step pipeline. A signed certificate per document. A product workspace shipping Q4 2026 — and a public matrix that grounds every country-specific claim we make.
Amavita Sciences™ is not a language services agency. It is regulatory language infrastructure — the layer between a source dossier written for NMPA, PMDA, MFDS, EMA, or AMAR and a submission-ready file that COFEPRIS, ANVISA, INVIMA, ANMAT and eight more LATAM regulators accept on the first pass.
What infrastructure means today
Jurisdiction rules engine
Every language, format, and submission rule cited to the resolution, decree, or circular behind it — dated. A lot of vendor knowledge in this market is still quoting from 2019; the matrix is refreshed against the 2024–2025 revisions.
Translation memory + glossary
Direct source-to-target into es-419 and pt-BR with per-client terminology memory. No English pivot. No drift. No second-party terminology re-decision that a regulator will flag as inconsistent across the dossier.
Audit logging
A signed certificate of accuracy per document and per linguist. Bilingual Layout A deliverables where the source page and the target page are legible side by side. The file leaves us with its own proof of care.
The pipeline
Origin-language dossier arrives in Chinese, Japanese, Korean, German, French, Italian, Hebrew, or English.
Direct source-to-target into es-419 and pt-BR. No English pivot, no drift, no second-party terminology re-decision.
Bilingual clinical review by reviewers who read the origin language and hold LATAM regulatory experience.
Country-by-country check against 12 LATAM primary instruments (resolutions, decrees, and circulars, dated).
Bilingual Layout A deliverable with a signed certificate of accuracy, per document and per linguist.
The file leaves us in the format the regulator expects on the first pass. No English intermediate to explain.
Product preview — Q4 2026
The document workspace we are shipping in Q4. Every step of the pipeline is captured, timestamped, and evidenced — so the file that reaches the regulator arrives with its own proof of care.
Document
Protocol-Kardia12L-v3.pdf
Turnaround shown is the median for a 40-page protocol in the current pipeline. SLA on Tier 1-A: submission-ready within 5 business days of intake, or the day-late credit applies.
What this replaces
A shared inbox, a spreadsheet, and eleven separate vendors emailing files that were re-translated from an English intermediate two weeks ago.
What ships today
Bilingual Layout A deliverables, signed certificate of accuracy, and the free public matrix that grounds every country-specific claim we make.
What's coming next
Q4 2026
One dossier, 12 regulators, one audit trail. Interactive product built on the pipeline shown above. Every timestamp, every reviewer signature, every regulator readiness gate visible in a single view.
H1 2027
Throughput, review cycle time, and finding categories aggregated across every batch a client runs with us. The data that lets a regulatory affairs lead answer "why is this dossier slower than the last one?" without opening ten emails.
H2 2027
Programmatic upload, status polling, and certificate retrieval so Amavita Sciences™ becomes a step in your existing regulatory affairs stack, not a shared inbox you copy files into.
Category names are contracts. Every item above is a commitment made by Amavita Sciences™ to build — not marketing language dressed up as a roadmap. If the timeline slips, this page changes.