Pharma Translations Done Right: Best Practices for Regulatory Submissions

By Rachel Lambert | rachellambert.biz | Copywriting | Content Creation | White Papers | Technical Writing

Rachel Lambert

The pharmaceutical industry is built on precision, and every detail matters. When it comes to regulatory documentation, accuracy isn’t just a preference; it’s a requirement. Expanding into global markets means submitting pharmaceutical documents in multiple languages while complying with varying strict regulations. Although that sounds like a lot of fun itself, this is when a minor translation error could mean approval delays, costly revisions, or, in worst-case scenarios, patient safety risks. When dealing with pharma translations for regulatory submissions, how can Atlas Translations help them get their translations compliant? How do we make sure your multilingual research will go ahead without compliance headaches?

Let’s explore some best practices for regulatory submissions and how we can help your company through this complex but crucial process.

Why Regulatory Translations Matter in the Pharma Industry

From Research and Development to Market

Before a new drug ever reaches the market, it goes through years of research and clinical trials—often across multiple countries. Regulatory documents must be accurately translated at every stage:

• From clinical trial protocols and informed consent forms to safety reports and compliance brochures.
• International clinical trials require multilingual documentation to meet the compliance standards of different regulatory bodies.
• Translation errors can lead to misinterpretation of trial results, which could delay or even halt approval processes.
• Poorly translated patient-reported outcomes could skew trial data, affecting the drug’s success.

Simply put, getting translations right early in the process is just as important as in the final regulatory submission phase.

Compliance with Global Health Authorities

Regulatory submission frameworks vary from region to region. Pharma companies must align translations with the specific requirements of bodies like:

• European Medicines Agency (EMA) – The regulatory agency of the European Union (EU) with a mission to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public and animal health.
• US Food and Drug Administration (FDA) – In the United States, the FDA regulates the safety and effectiveness of human and veterinary medicines, biologics, and medical devices. They also regulate the safety of food, cosmetics, devices that emit radiation, and tobacco products.
• Medicines and Healthcare products Regulatory Agency (MHRA) – The MHRA regulates medicines, medical devices and blood components for transfusion in the UK.
• Pharmaceuticals and Medical Devices Agency (PMDA) – Japan’s regulatory body that evaluates the quality, efficacy, and safety of drugs, medical devices, and cellular and tissue-based products.

Each regulator has different expectations, formatting requirements, and specific terminology that must be used consistently across all documents.

Avoiding Costly Delays and Errors

Regulatory authorities do not tolerate mistranslations. If key terms, dosage instructions, or safety warnings are mistranslated, authorities can:

• Reject applications outright, forcing companies to redo their submissions.
• Request additional clarifications, leading to time-consuming back-and-forth communications.
• Impose fines or legal consequences in severe cases.

For pharmaceutical companies, time is money. A delayed approval can mean millions in lost revenue, not to mention the potential risks to patient health.

Patient Safety and Trust

By far, the most important reason for accurate regulatory translations is that they can save lives.

Imagine a drug label where dosage instructions are mistranslated. Or a patient information leaflet with incorrect warnings. Inaccuracies like these can put patient health at risk and erode trust in the brand.

Providing clear, consistent translations across all documentation—from research and development through to post-market safety updates—is key to avoiding such risks.

The Challenges of Translating Regulatory Documents

Of course, nothing is ever simple. The more regulated the industry, the more difficult the regulatory translation. And, a good regulatory translation isn’t as simple as converting text from one language to another. Here’s why:

Complexity and Technicality

• Pharmaceutical and regulatory documents are packed with highly technical and specialised terminology that requires subject-matter expertise.
• To which end, words can’t just be translated literally—they need to align with industry-approved terminology to avoid misinterpretation.

Ever-Changing Regulations

• Different markets update their regulations frequently, and translations must always reflect the latest standards.
• Keeping up with evolving terminology and legal requirements requires a dedicated team of linguists with up-to-date knowledge.

Stringent Quality and Consistency Requirements

• Pharma translations must be 100% accurate and consistent—a single inconsistency can be flagged as an error by regulators.
• With thousands of pages to translate, maintaining terminology consistency across multiple documents and languages is a massive challenge.

Large Volumes and Tight Deadlines

• Regulatory filings are extensive, often running into thousands of pages per submission.
• Tight regulatory deadlines mean companies can’t afford translation delays—they need fast, accurate, and scalable solutions.

Best Practices for Streamlining Multilingual Regulatory Submissions

1. Work with Professional Specialist Translators

Sad to say, but not all translation agencies are created equal—regulatory translation requires pharma-specific expertise. Atlas Translations will only work with translators who have sector-specific experience within the pharmaceutical, health, and medical industries.

• Remember that a generalist translator won’t cut it—these documents need native-speaking linguists who specialise in pharmaceutical regulatory affairs.
• Industry experts understand compliance terminology and make sure the right terminology is used for each regulatory body.

2. Use Translation Memory and Terminology Management Tools

• Translation Memory (TM) stores previously translated segments, allowing for faster and more consistent translations.
• Terminology Management Systems (TMS) are a centralised glossary to maintain accuracy and standardisation across documents.

These tools are software that are usually specific to the translation industry. In the form of local or cloud-based databases holding glossaries or dictionaries, they speed up the process and reduce the risk of terminology mismatches.

3. Implement a Robust Quality Assurance Process

Translation errors are not an option in regulatory submissions. A multi-step quality control process should include:

• Back translation which involves, as the name says, translating back to the original language to check for discrepancies.
• Linguistic validation where we make sure the translation matches the intended meaning without ambiguity.
• Native language review is part of the translation process as translated documents are checked by native-speaking experts familiar with the local regulations.

4. Plan for Localisation Early in the Regulatory Process

• Translation should never be an afterthought—it should be integrated into the submission timeline from the start.
• Proactively planning for localisation prevents last-minute errors and rushed translations, which can lead to compliance issues.

5. Leverage Technology and AI Responsibly

• Machine translation (MT) and AI tools can speed up repetitive translations but should never replace human expertise in regulatory translation.
• When human expertise is essential:
  • Regulatory filings, safety documentation, and patient information leaflets.
  • Any content where precision is paramount.

Technology supports the process, but expert, human linguists are non-negotiable.

How Atlas Translations Provides Support to Pharmaceutical Companies

At Atlas Translations, we understand the high stakes of regulatory translation.

• Our specialist pharmaceutical translators have in-depth knowledge of regulatory terminology and compliance requirements.
• We use any necessary technology to provide consistency, speed, and accuracy.
• As assigned Project Manager will guide your project from “soup to nuts” keeping you constantly updated.
• Our rigorous quality assurance process guarantees that translations meet the highest regulatory standards.

Whether you need translations for clinical trials, drug approval submissions, patient leaflets, or compliance documents, we’ve got you covered.

It’s a Wrap!

Translating regulatory documents for global markets is no small task—but getting it right is crucial for compliance, market access, and patient safety.

By working with experienced translators who have sector-specific pharmaceutical backgrounds, leveraging technology wisely, and prioritising quality assurance, Atlas Translations can help your company streamline the translation process and avoid costly mistakes.

Regulatory translation isn’t just about ticking boxes—it’s about keeping things accurate, protecting patients, and successfully bringing life-changing medicines to market.

Contact Us

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