Insights

Across the life sciences industry, language is more than just a communication tool; it's essential for maintaining regulatory compliance. Whether launching a pharmaceutical product, submitting a medical device dossier, or preparing safety data for chemicals, multilingual compliance is critical. It's not simply a requirement; it’s a strategic enabler that facilitates market access, reduces risk, and fosters trust.  How can life sciences companies communicate complex information across borders without losing meaning or risking compliance? That’s where Avantpage Life Sciences comes in, offering clarity through expertly managed translation processes.  The EU provides a harmonised regulatory framework, but each member state can enforce its own language and documentation standards. This dual-level challenge demands mastery of both EU-wide mandates, like EMA, MDR/IVDR, REACH, and local expectations.  In 2025, regulators are prioritising linguistic accuracy and cultural relevance, especially for patient-facing content. Planning early with expert support is more crucial than ever. Failure to meet both regional and EU-specific requirements can delay approvals and erode trust. Proactive, strategic language solutions are no longer optional but mission-critical. Choosing a language service provider goes beyond evaluating language proficiency. To meet regulatory requirements, translations must comply with ISO 17100 standards and, just as importantly, reflect a deep understanding of the life sciences domain. A qualified provider should be familiar with clinical trials, SmPCs, pharmacovigilance reports, and technical documentation.  That’s why at Avantpage Life Sciences, we work with professionals who are trained in both language and the scientific context, ensuring that translations meet the expectations of regulators and industry stakeholders alike.  But what does it take to get it right? Below, we highlight key elements that demand close attention when it comes to regulatory translation in the life sciences industry. Tools and technology designed to augment expert work, rather than replace it: 
These innovations enable faster delivery, higher accuracy, and greater audit-readiness.  A multistage QA approach is applied to ensure accuracy and compliance. It includes:  We also maintain version control and detailed audit trails, ensuring that your submissions withstand regulatory scrutiny.  Localisation goes beyond language: it requires cultural awareness and contextual understanding. In regulatory contexts, patient-facing materials such as IFUs, informed consent forms, and leaflets must be adapted to reflect local norms while maintaining compliance. This approach is part of the methodology adopted by Avantpage Life Sciences in its work with life sciences content. By aligning linguistic precision with cultural relevance, we help ensure that critical information is both understood and trusted by local audiences. The life sciences industry is in constant motion, shaped by new regulations, emerging technologies, and shifting patient expectations. To stay ahead, we invest heavily in continuous training for our linguists and project managers, ensuring they’re up to date with the latest regulatory guidelines, terminology standards, and industry best practices. We don’t just react to change — we build it into our workflows. By actively incorporating client feedback and regulatory updates, we refine our processes in real time, delivering translations that are not only compliant but consistently aligned with the evolving demands of global healthcare markets. Data protection is a core concern in the life sciences sector, where sensitive information is handled daily. Ensuring confidentiality, transparency, and ethical responsibility involves strict adherence to security protocols, from NDAs to encrypted file exchanges. These standards are integral to the practices followed by Avantpage Life Sciences. Our workflows are designed to align with industry-specific data protection regulations, including GDPR and HIPAA, ensuring secure handling at every stage of the translation process. Across life sciences, the consequences of inadequate translation can be far-reaching: regulatory delays, reputational harm, and, in some cases, clinical risk. Multilingual compliance should therefore be treated as a core strategic function rather than an afterthought.  Avantpage Life Sciences plays a role in this space by aligning linguistic accuracy with regulatory demands and cultural expectations, helping ensure that communication remains clear, compliant, and locally appropriate across markets.  As the industry becomes more global, language plays a critical role in ensuring safety, building trust, and gaining access to new markets Ready to strengthen your multilingual compliance strategy? Contact Avantpage Life Sciences to learn how we can support your global success.  Let’s go beyond words, together. 

In the dynamic landscape of the life sciences industry, collaboration can be key to overcoming complex challenges and delivering exceptional results. Recently, Avantpage Life Sciences and EmTex Life Science joined forces to address an MDR compliance challenge presented by a leading medical imaging solutions manufacturer. This collaboration exemplifies the power of strategic partnerships in providing comprehensive, one-stop solutions tailored to the needs of our clients in this highly regulated sector.  The client approached Avantpage Life Sciences with a specific request. They needed their most recent Instructions for Use (IFU) translated into five languages, but also needed support with the crucial step of checking MDR compliance with EU standards. As the source text is written at their headquarters in Japan, ensuring MDR compliance with Medical Devices Class 1 EU regulations is essential. The client typically conducts MDR compliance checks in-house but, in this instance, requested that Avantpage include the task in the project scope. Given the crucial nature of both MDR compliance and linguistic accuracy, Avantpage leveraged their partnership with EmTex Life Science to tackle this challenge head-on.  EmTex Life Science, a provider of medical writing and communication services based in Belgium, brought over two decades of experience in regulatory medical writing to the table. Their EU regulatory compliance specialists meticulously reviewed the English text against EU Medical Device Regulation (MDR) standards, ensuring that the content met the necessary requirements.  Once the English text received the MDR compliance stamp of approval from EmTex Life Science, Avantpage’s team of expert linguists translated the IFU into five languages: French, German, Italian, Spanish, and Turkish. As subject-matter experts in the field, Avantpage’s teams ensured linguistic accuracy and cultural nuances were preserved throughout the translation process.  In addition to translation, Avantpage’s graphic design team played a crucial role in the project by reformatting the translated files, ensuring consistency and readability across all languages. The result was a set of IFUs that not only met MDR compliance standards but also provided clear and accessible instructions to end-users in diverse linguistic markets. Beyond delivering the translated IFUs, Avantpage went the extra mile by creating a post-project glossary for use on future client projects and updates.   Avantpage Life Sciences was delighted to partner with EmTex Life Science on this MDR compliance project as our respective company offerings are the perfect complement to one another. Both companies are trusted partners for the life sciences industry, and both are focused on what we know we do best. Avantpage’s linguists are experts in clinical trials, pharmaceuticals, medical devices, and biotech, and the company is ISO-certified. EmTex Life Science brings a wealth of expertise in medical writing and communications services to the table, with writers specializing in preclinical, clinical, pharmacokinetics, pharmacodynamics, and quality of life. Through their EmTex Academy, they also offer professional courses within the life science industry, further demonstrating their commitment to excellence and knowledge sharing.  Client testimonials speak volumes about the success of the collaboration between Avantpage and EmTex Life Science. Sales and Marketing Manager at a global manufacturer of imaging solutions, praised the seamless experience and expressed confidence in Avantpage’s continued support in navigating complex regulatory landscapes. “This was the first time we worked with a different vendor and also the first time we asked an external partner to check MDR compliance. Things were very smooth with Avantpage, who will soon begin assisting with the complex IFU update process.” – Sales and Marketing Manager at a global manufacturer of imaging solutions In conclusion, the partnership between Avantpage and EmTex Life Science exemplifies the power of collaboration in the life sciences industry. By leveraging each other’s expertise, these two industry leaders provided the client with a comprehensive MDR compliance solution that addressed their unique challenges and exceeded expectations. As the life sciences landscape continues to evolve, partnerships like this will play an increasingly vital role in driving innovation, compliance, and success for clients worldwide.