Regulatory Submissions Translation Services (UK)

When submitting to the MHRA in the UK or the EMA across Europe, translation accuracy isn’t optional… it’s essential. One mistranslated dosage instruction or inconsistent term can delay approvals, trigger costly queries, or jeopardise patient safety.

At Tongue Tied, we offer a UK-specific, compliance-focused translation service tailored for pharmaceutical, biotech, CRO, and medical device clients. In 30+ years, we’ve helped over 2,600 organisations submit accurate, on-time dossiers to health authorities.

What Is a Regulatory Submission? 🧾

A regulatory submission is a comprehensive dossier submitted to approve new or updated medicines and medical devices.

Key document types include:

• CTD/eCTD modules (CTD: Common Technical Document; eCTD: electronic format)

• Clinical Trial Protocols

• Informed Consent Forms (ICFs)

• SmPC (Summary of Product Characteristics)

• Patient Information Leaflets (PILs)

• Investigator Brochures

• Risk Management Plans (RMPs) / Safety Reports

• Adverse event notifications

• Product labelling & packaging content

Each follows EMA or MHRA templates (e.g. UK QRD format). Many multinational trials or EU markets require submitted documents in multiple languages, or in English plus target languages.

Why Precision in Translation Matters

⚠️ Risks of Poor Translation

• Approval delays or rejection: Health authorities, especially the MHRA, have tight terminological expectations.

• Patient safety risks: Misinterpreted dosage or procedural instructions can lead to serious harm.

• Financial consequences: Errors may require repeat submissions, audits, or legal redress.

• Operational reputation damage: Repeated quality problems diminish credibility with regulators.

Mini-case example: A European client submitted an ICF where dosage instructions did not match the SmPC wording. MHRA flagged the discrepancy, delaying approval. We performed a full terminology audit using EMA QRD templates, corrected all entries, and the resubmission passed without further queries.

Our UK‑Focused Translation Workflow

Here’s our enhanced process, designed for UK/EU dossiers and quality assurance:

1. Document Intake & Regulatory Review

We assess submission type (e.g. Type II variation, initial MA), examine formats, file types (Word, PDF, eCTD), and check for standard templates.

2. Terminology & Glossary Setup

We align terminology with MedDRA, ICH-GCP, UK QRD standards, and your previous glossaries. Ensures consistent usage across modules.

3. Translation Memory (TM) Integration

Using advanced TM tools, we detect and omit repeated segments, reducing cost and turnaround. For example, TM Lewin saved 85% by eliminating repeated onboarding content.

4. Translator Assignment

Experienced translators with life sciences or medical-device sectors are assigned based on protocol type or therapeutic area.

5. Editing & Quality Assurance (ISO 17100)

A second linguist reviews each segment against ISO 17100. QA includes terminological consistency, regulator format compliance, and reading flow.

6. In-Country Review or UK Regulatory Check

Optional final review by a UK-based regulatory expert fluent in target language. Especially useful for jurisdiction-sensitive terms like UK-specific dosage phrasing or UK clinical trial nomenclature.

7. Formatting & eCTD Assembly

Final XML or module formatting to EMA eCTD standards (Modules 1–5). Zip output or submission-ready package.

8. Delivery & Client Support

Clear messaging, version file control, and compliance alerts (e.g. glossary queries) until submission acceptance.

This process ensures aligned translation quality with UK/EU standards, maintains cost control, and keeps communication transparent.

How We Deliver EEAT and Trust

• Experience: 30+ years in translation for regulated industries; over 2,600 clients delivered.

• Expertise: Every translator holds a sector-specific qualification, often as ITI members. We are ISO 17100 certified with regulated QA.

• Authoritativeness: We reference EMA/MHRA templates, MedDRA, ICH‑GCP guidelines, translators are familiar with these.

• Trustworthiness: Real client testimonials (e.g. NHS, BUPA) and a track record of zero submission rejections due to translation issues.

Stand-Out Differentiators

Differentiator	Why It Matters
UK Regulatory Focus	Few providers emphasise MHRA-specific phrasing and standards
Demo Case Study	Real example showing measurable benefit (e.g. approval speed)
AI + Human Translator Combo	Explains technology aids without sacrificing human control
UK Terminology Experts	Native nuance for English + local regulatory phrasing
FAQs with UK Specifics	Tailored to regulatory cues much more detailed than generic overview

Pricing, Turnaround & Scalability

Typical turnaround estimates:

• Clinical trial protocol: 3–5 working days

• PIL or SmPC: 2–3 working days

• Full eCTD dossier: timeframe set per volume/languages

Pricing structure:

• Fixed price per word or per project

• No charge for repetitive text segments identified via TM

• Scalability: our team can handle large, multi-language submissions across 20+ language pairs.

FAQs (UK-Focused)

Do MHRA submissions require translation?Only if materials include text in another language than English or are meant for multi-language trials with participants speaking other languages.

Can you translate changes or addenda to existing documents?Yes. We reuse your original glossary and TM, so updates are quicker and more cost-efficient.

What languages do you support?All EU languages plus Asian, Middle Eastern and African languages. We assign expert translators for each field and language pair.

Is rush service available?Yes… where volume and language allow, we offer priority turnaround.

Do you offer in-country UK review?Yes, optional UK regulatory expert check for critical sections like dosage wording, consent forms, and titles.

Next Steps

Ready to submit an accurate, MHRA‑compliant dossier with confidence? Get in touch:

📧 sales@ttmltd.com📞 +44 1606 352 527

Prefer to chat with Richard? Connect via LinkedIn for friendly and expert advice.