CTD/eCTD modules, study documents, pharmacovigilance & safety communications, IFUs/ICFs, and regulator‑facing content — translated with reviewer‑independent checks, bilingual redlines, terminology governance, LQA, and full audit trails. Solid, defensible language that holds up under authority review.
Use this guide to decide why pharma/biotech teams invest in multilingual content operations (regulatory defensibility, patient safety, speed to market) and when to engage (new markets, eCTD filings, PV spikes, labeling changes, tech transfers, audits).
Consistent terminology, CTD context preserved, and bilingual diffs reduce authority comments.
ICF/PIL require plain-language adaptation and stable risk phrasing across markets.
TermOps + reviewer independence cut rework cycles and accelerate submissions.
CCDS → SmPC/PIL/USPI alignment, artwork proofing, and braille handoffs prevent drift.
Signed PDFs, change logs, and access trails keep audits predictable.
In a globalised pipeline, language work is a legal, ethical and operational requirement. A specialised partner makes submissions defensible, patient-facing materials readable, and cross‑market content consistent — all with evidence, security and speed. Below is an at‑a‑glance view of the roles a pharma‑ready language partner fulfils.
In short, a specialised language partner is the bridge that makes global pharma operations safe, compliant and fast — bringing therapies to patients across markets.
From discovery to post-market, we run multilingual operations that keep regulatory packs defensible, patient materials readable, and labeling consistent across markets. Expect CTD/eCTD-aware localisation, linguistic validation for ICF/PIL, artwork & braille handoffs, PV lanes, and CMC document control.
Use this practical checklist to evaluate language partners for CTD/eCTD-aware localisation, clinical documentation support, labeling & IFU adaptation, pharmacovigilance lanes and CMC document control. Toggle requirements to see your readiness score, then compare up to three vendors side-by-side.
| Requirement | A | B | C |
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Teams search for things like: “German SmPC translation for EMA,” “ICF into Arabic (UAE),” “eCTD-ready French to English,” “PSUR translation for MHRA,” “Hindi patient leaflet for CDSCO.” We deliver these day-to-day with regulatory-grade localisation, linguistic validation for patient materials, and secure delivery backed by ISO 17100 & 27001.
Browse common pharma/biotech documents by category. Open a card to see scope notes and the evidence bundle (bilingual diffs, signed PDF, audit log). Use filters or search e.g. “CTD eCTD”, “ICF Arabic”, “SmPC German”, “PSUR MHRA”, “batch record Polish”.
Hover/drag to tilt the cards. Each tile uses a 3D perspective layer, giving you a tactile sense of the content categories we handle most in life sciences.
Authoring‑aware translation for M1–M5 with consistent terminology, cross‑references and links intact.
Clinical protocols, investigator brochures and statistical plans with medical review and diffs.
Comprehensive reports translated with reviewer‑friendly track changes and citations preserved.
PIL/SmPC/USPI aligned to CCDS/CCSI; carton/leaflet artwork with braille handoffs.
Signal‑driven Dear HCP notices and safety updates — overnight lanes with full traceability.
Batch records, stability data, specs and methods handled with tight version control.
Click any icon to pin it; the orbit continues in the background. We use this wheel during scoping to surface labeling nuances that impact translation choices.
Tokens represent files moving through our controlled steps. The lane runs continuously to mirror real production; pause on hover to inspect.
Regulatory translation, Website localisation and Certified orders are commonly paired with Pharma ops. Explore details or talk to us about a combined plan.
Five CTD modules adapted from CCDS to market variants with terminology locked upfront. Independent review + bilingual diffs meant authority comments were resolved in the first round. Artwork and braille handoffs included file‑level evidence for every revision.
Signal‑driven Dear HCP notices across EU markets with rapid triage. Reviewer‑independence and redlines kept the language tight while LQA ensured risk phrasing was uniform. Signed bundles delivered before start of clinic day with clear change logs.
Every deliverable has a second‑pair review by a linguist who did not translate the file, so errors don’t get reinforced. We also enforce TermOps locks at intake: once terminology and abbreviations are agreed, they are frozen, versioned and referenced across files. Together, these controls produce cleaner, more defensible translations and far fewer comments from authorities.
Yes. We generate bilingual diffs that show exactly what changed, why, and when. Reviewers can scan side‑by‑side segments, accept/reject changes, and route clarifications. When you need a signed package, we include the diffs plus source/target bundles and a change log covering each revision.
We translate within CTD context and preserve cross‑references, numbering and links. For market variants, we start from a CCDS baseline and adapt to local rules; artwork handoffs include braille where needed. Each file carries its own evidence trail so internal QA can validate quickly.
We build a compact term base early, seeded from your materials and authority phrasing. It is locked at intake, reviewed with SMEs where needed, then enforced across translators and reviewers. The result is a stable lexicon that reduces corrections and keeps multi‑market packs coherent.
Yes. For PV bursts, we spin up a dedicated lane with pre‑cleared linguists, an on‑call reviewer and a lean approval path. Files move with timestamps, responsible owners and diffs so you retain complete traceability while meeting overnight or same‑day windows.
Access is SSO‑gated with least‑privilege roles. Files are encrypted at rest and in transit; delivery happens over secure channels only. Reviewer access is time‑boxed and activity‑logged; on release, we can include signed PDFs and an exportable audit trail for your records.
At iCONiC Translation World, we operate with reviewer-independence, lock terminology via TermOps, deliver bilingual redlines, and preserve CTD/eCTD context end-to-end — across clinical, labeling, PV and CMC — under ISO 17100 & ISO 27001 with secure exchange and audit trails.
Tell us what you need translated and when it must be review‑ or submission‑ready. We’ll adapt to your study cadence and provide the evidence your reviewers expect.