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For Life Sciences

Multilingual content for pharma that ships fast,
and proves every step.

OTTO doesn't just translate your regulated content. It works out what each document needs, produces it, checks it, and keeps a record of every step, so your team moves faster and can show its work when someone asks.

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Patient leaflet
EN to FR-CA · v4
Live
Classified
high risk · regulated
RCC
Grounded
product glossary v4
ALL
Scored
fluency · accuracy · terms
98
Routed
expert review
QEE
Approved
logged 14:02 · signed
M.S-J
Built for content a regulator actually reads.
Every step recorded. Nothing to reconstruct later.
The reality

You're shipping regulated content faster than your review process can keep up.

Labels, instructions, consent forms, study reports: all into 30+ languages, each one answering to a different authority. The volume keeps climbing. Checking it all by hand doesn't.

Every authority wants it its own way

The FDA, EMA, Health Canada and every national regulator expect different formats, wording and paper trails. Lining one product up across all of them eats weeks of specialist time.

Review is the bottleneck, not translation

Drafting got fast. Checking, reconciling and signing off didn't. It still happens one document at a time, by hand, exactly where delays cost the most.

If you can't show your work, you can't defend it

When someone asks why a term changed, "the translator decided" isn't an answer. Most setups can't tell you who changed what, when, or why.

Use cases

OTTO meets life sciences
where the content lives.

Three families of regulated content. Three workflows. One governance layer.

01 · Pharma & Biotech

From product label to patient leaflet, audit-ready in every market.

OTTO sorts every document — labels, leaflets, safety reports — sends each one through the right workflow, and surfaces only what your team needs to check.

Product labels & packaging

Translated, versioned and kept consistent across every market, with a record of every change.

Patient leaflets

The information patients actually read, produced in every required language and checked for the right terms.

Safety reports

Drug-safety content translated with the correct medical wording, locked so it stays consistent everywhere.

Promotional & medical materials

On-brand, on-claim content for every market, checked against what's approved before it goes out.

1 source asset → 27 EU languages → QRD-compliant SmPCs
02 · Clinical Research

Faster site startup, without blowing up your translation budget.

From consent forms to patient questionnaires, OTTO produces every trial document in every language a site needs — and keeps the proof it was done right.

Informed consent forms

Produced for every site and language, worded so patients understand and ready for ethics review.

Patient questionnaires

Outcome questionnaires translated and validated so results stay comparable across countries.

Investigator documents

Site-facing materials kept current and consistent as the protocol changes.

Patient-facing trial materials

Recruitment and visit materials produced fast, in plain language, for every market.

1 protocol → 14 sites · 6 cohorts · consent forms in every language
03 · Medical Devices

Device content ready for Europe, Canada and the world, from the manual to the box.

OTTO handles every word that ships with a device - instructions, packaging, on-screen text - in every market you sell in, with the trail to prove it.

Instructions for use

Translated for every market and kept in sync with the source, with a full change history.

Packaging & labeling

Box and label content produced for every region and checked before print.

Software & on-screen text

The text inside the device or app, translated and kept consistent with the manual.

Post-market materials

Field updates and surveillance content produced quickly when something changes.

1 device → 40+ markets · EU-ready labeling · every change traced
Most platforms translate. OTTO decides.

Traditional translation vs.
a platform that decides.

The same content can go through either one. Only one of them gives your team a real answer when a regulator asks "why did this change?"

Traditional translation OTTO
How it decides The tool translates. People decide everything else, off to the side. OTTO reads each piece, decides how it should be handled, and records why.
Quality checks A person reviews the whole thing at the end, by hand. OTTO checks every part as it's produced, and flags only what needs a human.
The paper trail Scattered across emails, comments and spreadsheets. One clean record: who, what, when and why — for every change.
When something changes Re-run the file. Re-check everything. Only the affected parts are redone and re-checked. Nothing else moves.
What you actually get A translation service. A platform that decides, produces and proves, in 60+ languages.
The rules you answer to

Made for the toughest
regulators in life sciences.

OTTO doesn't just say it's compliant. Every workflow comes with a clear, documented answer to the standards your team has to defend — in plain words, with the official reference where it matters.

21 CFR Part 11

The FDA's rules for electronic records and signatures

What OTTO gives you Every action is signed and tied to a person, and nothing in the history can be quietly overwritten.

EU Medical Device Regulation

Europe's rules for device instructions and labeling

What OTTO gives you Content is traced from the source to every market, with the full history of what changed and when.

EMA product information

Europe's templates for labels and patient leaflets

What OTTO gives you Labels and leaflets produced against the current European templates, in every required language.

HEALTH CANADA

Canada's rules for bilingual labelling and product monographs

What OTTO gives you Labels and monographs produced in English and French together, consistent across both, with the trail Health Canada and Québec (Loi 96) expect.

Safety reporting

Pharmacovigilance and drug-safety documents

What OTTO gives you Safety reports translated with the right medical terms, locked so they stay consistent everywhere.

Data protection & residency

GDPR and where your data lives

What OTTO gives you Your content stays in your own environment. We don't train on it, and it can stay in the EU on request.

FAQ

Straight answers for regulated teams.

Something specific to your workflow? Talk to our team and we'll walk through it.

Can we really let AI near regulated content?

That's exactly why OTTO decides first. Before anything runs, RCC classifies each document by risk, complexity and regulatory sensitivity. Low-risk content moves automatically, high-risk content like labels, safety and monographs is held for expert review. AI never gets the final word on the content that can hurt you. 

Will this hold up in a validated, regulated environment?

Yes. Every action is logged, signed and tied to a person, and the history can't be quietly overwritten. When an auditor asks why a decision was made, you show them the record as it was produced, not a reconstruction after the fact.

When a label or monograph changes, how does OTTO update every market?

It re-runs only the affected parts and re-checks them. Unchanged content stays as it was, the change is traced, and every market version stays aligned to the same source. No full re-translation, no silent drift. 

How does OTTO handle markets that require more than one official language?

It produces each language together and keeps them consistent, against the terminology and templates each authority expects. Where a market requires two official languages on the same product, like Canada, both stay aligned instead of being translated and checked separately. 

How does OTTO keep our validated medical terminology consistent?

It grounds every output in your own glossaries, translation memories and references, per document. Approved terms like MedDRA and product glossaries stay locked instead of drifting between drafts. 

What happens to our clinical and patient data?

It stays in your own environment. We don't train on your content, and it can stay in-region (EU, Canada or wherever you need it) so sensitive trial and patient data never leaves where it's allowed to be.

Does OTTO replace our medical and regulatory linguists?

No. It removes the low-risk volume and the manual checking, so your linguists spend their time on the high-stakes content where their judgment actually matters. 

Get Started with
OTTO today.

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