Tomedes Accurately Translates Portuguese Pharma Documents for UK & MHRA Registration

The client

Company name: AGI (Pseudonym)
What does the company do?
A global pharmaceutical company specializing in regulatory affairs and healthcare solutions.
Deadline set by the client: 3–5 days
What do they need?
The client needed a full translation of a Brazilian regulatory document—RDC 166, focused on pharmaceutical validation—from Portuguese into UK English.

The content had to be compliant, technically accurate, and preserve the exact formatting of the original document, in line with MHRA compliance and broader medical healthcare document translation standards.

The challenges

Even with nearly two decades of experience translating pharmaceutical documents in line with MHRA compliance, the Tomedes team faced a few challenges in this project.

From strict formatting requirements to ensuring regulatory accuracy, we worked through multiple layers of complexity to deliver a fully compliant and professional result..

Firstly, the original guideline included numbered sections, tables, and specific formatting that had to be exactly matched in English. Studies show that over 60% of regulatory rejections are due to formatting errors.

To avoid this, Tomedes paid close attention to every detail to ensure the translated document stayed clear, consistent, and MHRA-compliant.

Secondly, pharmaceutical validation documents use complex terms about drug production, testing, and quality checks. Nearly 75% of medical translation errors come from incorrect use of technical terms.

Tomedes made sure every term followed current medical regulations and was accurately translated by experts.

Thirdly, the client needed the translation to follow UK English rules and meet UK medical device regulations. Some data has shown that poor translation causes up to 30% of approval delays.

This meant more than fixing spelling—it required full alignment with MHRA standards so the document could be used right away without extra edits.

Why Tomedes?

Tomedes is a translation company that specializes in pharmaceutical translations, including compliance documentation, clinical trial materials, and validation guidelines.

Tomedes translators are not only native UK English speakers but also possess industry-specific knowledge, ensuring every term, instruction, and clause is rendered with technical precision in accordance with medical compliance certification expectations.

What sets Tomedes apart is its integration of expert linguists with proprietary AI-powered QA tools, allowing for real-time consistency checks and error detection.

This combination enhances both accuracy and efficiency, making the translations reliable and fast. With dedicated project managers and 24/7 client support, we provide dependable document translation services in the UK, tailored to strict regulatory and compliance needs.

The solution

To meet the client’s high standards for regulatory accuracy and formatting fidelity, Tomedes implemented a strategic, multi-layered approach. By combining human expertise with advanced AI tools, we ensured a smooth, efficient translation process from start to finish.

First, we assigned a professional linguist with specialized experience in pharmaceutical regulations and medical compliance.

Their deep understanding of drug validation protocols and regulations about medical records, as enforced by bodies like the MHRA, ensured every term and concept was translated with precision and regulatory relevance.

Second, Tomedes AI tools were used to scan the document for terminology consistency, flag any formatting discrepancies, and assist in maintaining the original structural layout.

This technology-supported review helped streamline the process while ensuring alignment with all necessary medical regulations.

For example, Tomedes used its AI-powered Pre-Translation Toolkit to prepare the document by spotting key medical terms in both the source and target languages, like Clavoxinate Sódico and Estudos de Estresse e Degradação Forçada.

It also checked for formatting issues and created a glossary, helping ensure accuracy and regulatory compliance from the start.

Finally, we delivered the completed translation in both PDF and editable DOCX formats, ensuring the client had flexible, ready-to-use versions.

The final documents mirrored the original layout precisely while reflecting accurate, regulation-compliant UK English throughout.

The result

Tomedes successfully delivered the translated pharmaceutical guideline within the agreed 3–5 day window, meeting the client’s deadline without compromise.

The translation adhered to all relevant compliance standards, making it suitable for immediate regulatory use and medical affairs compliance reporting.

The formatting of the translated document was preserved exactly as in the original Portuguese version, including all tables, numbering, and layout structure.

This attention to detail supported seamless integration into the client’s compliance monitoring MHRA workflow.

The client expressed strong satisfaction with both the quality and timeliness of the project.

Impressed by Tomedes’ performance, they are now considering Tomedes as a go-to partner for future pharmaceutical and medical compliance document translation needs.

Conclusion

Tomedes successfully delivered a precise regulatory translation for AGI, enabling smooth internal review and ensuring full alignment with UK medical laws and regulations. This case demonstrates the strength of Tomedes expert linguists supported by cutting-edge AI, helping clients achieve MHRA compliance with accuracy and efficiency.

Ensure your medical documents meet MHRA standards and UK regulations with Tomedes’ expert, compliant translation services. Get in touch with Tomedes for accurate, regulation-ready translations that support your success in the healthcare and pharmaceutical industries.