Regulatory Translation Services UK

In regulated industries, getting the translation wrong isn't just inconvenient, it's non-compliant. Whether you're preparing documents for the MHRA, FCA, or other UK regulators, your translation provider plays a crucial role in helping you stay compliant, consistent, and submission-ready. Here’s what you need to know about regulatory translation services in the UK.

What Are Regulatory Translation Services?

Regulatory translation involves translating documents that are submitted to official bodies like the Medicines and Healthcare products Regulatory Agency (MHRA), the Financial Conduct Authority (FCA), and other UK regulatory entities. These documents must be not only linguistically accurate but also terminologically precise and format-compliant.

Common Document Types:

• Pharmaceutical: SmPCs, PILs, Clinical Protocols, Risk Management Plans

• Medical Device: Instructions for Use (IFU), Safety Reports, Labelling, SSCPs

• Financial: AML/KYC policies, fund prospectuses, compliance manuals

Each carries strict linguistic, formatting, and legal standards. Regulatory translation is not a creative exercise, it’s about ensuring every term, definition, and section aligns with the relevant UK framework.

Why UK Regulatory Context Matters

Since Brexit, the UK has diverged from EU regulation, requiring companies to prepare MHRA submissions in parallel with EMA filings. This adds complexity:

• MHRA wording templates differ from EU QRD templates

• FCA documents must align with UK-specific legal frameworks

• Some documents may be submitted in English only, others require language adaptation for UKCA conformity

If you're operating across borders, you need a translation provider who understands both EU and UK nuances.

Types of Documents We Translate

At Tongue Tied, we cover:

Life Sciences:

• SmPC (Summary of Product Characteristics)

• Patient Information Leaflets (PIL)

• Clinical trial protocols & informed consent forms

• Risk Management Plans (RMPs)

• Pharmacovigilance and safety updates

Medical Devices:

• IFUs in XML, PDF, and eIFU formats

• Labels and packaging copy

• SSCP and PMS plans under MDR/IVDR

Financial & Legal:

• Anti-money laundering (AML) documents

• Know your customer (KYC) questionnaires

• Regulatory filings, shareholder communications

• Legal disclosures and fund prospectuses

The Challenges of Regulatory Translations

Regulated translation is about avoiding rejection and ensuring clarity.

Common challenges:

• Mismatched templates: Using EMA wording in MHRA docs causes delays

• Data confidentiality: Especially in pharma and finance

• Inconsistent terminology: Without proper glossary and TM use

• Version control issues: Particularly across multiple language versions

This is why a specialist provider matters.

Our Regulatory Translation Process (UK-Focused)

1. Document audit: We identify what needs translating, how it will be submitted (eCTD, XML, PDF), and which regulatory standards apply.

2. Glossary alignment: Our team uses MHRA, FCA, and IATE-approved terms, matched to your past submissions.

3. Translation memory (TM): Helps reduce cost and increase consistency.

4. Expert linguists: Native translators with specific sector experience.

5. Dual QA review: Our ISO 17100-compliant editors review every piece.

6. In-country UK compliance check (optional): Especially useful for novel therapies or high-risk submissions.

7. Secure delivery: All projects handled under GDPR and ISO 27001-equivalent processes.

Why Choose Tongue Tied for UK Regulatory Translations

With over 30 years of experience and more than 2,600 clients, we understand that in regulated markets, translation quality can affect licensing, product launches, or investor confidence.

• ISO 17100 certified for translation quality

• Member of ITI and ATC

• Experience across life sciences, medtech, and financial services

• Transparent pricing, clear timeframes, and secure handling

We’re trusted by everyone from start-ups to global pharma leaders.

Case Study: UK Pharma Client Submitting to MHRA & EMA

A mid-sized UK pharmaceutical company needed:

• SmPC, PIL, and Protocols translated into French, German, Spanish & Dutch

• MHRA-specific formatting and EU QRD template compatibility

• Cost-effective reuse of prior SmPC content

Solution:

• Translation Memory applied across updated SmPC and PIL

• ISO 17100 QA and in-country review for French and German

• Submission accepted with no linguistic queries raised

Result: Saved 70% on cost and delivered within 5 working days.

FAQs

Q: Can you translate for MHRA and EMA in parallel?Yes. We adapt phrasing, layout, and glossaries per regulator.

Q: Do you support unusual language pairs (e.g. Welsh, Arabic)?Yes. We offer 200+ languages including right-to-left and complex scripts.

Q: Can I use machine translation for early drafts?We can post-edit MT drafts, but for regulatory submissions, we recommend human-only translation to ensure compliance.

Q: Is in-country review required?Not always, but we recommend it for high-risk therapies or where localised phrasing affects clarity.

Get a Quote or Speak to Richard

We’d love to support your next submission. Email sales@ttmltd.com or call +44 1606 352 527.

Want to speak to a real human? Connect with Richard on LinkedIn for practical advice and free insights.

Tongue Tied. Trusted for compliant, clear, and consistent translation across regulated sectors.