In this age of globalization in healthcare and science, precise and compliant translation is no longer a choice – it is a requirement. Faced with a governed environment, life science organizations are under pressure to deliver documentation that meets the standards of an array of worldwide jurisdictions. At clinical trial protocols, product labels and regulatory filing, the preciseness of language is essential to both patient safety and product approval and market viability. This is the point where certified life sciences translation plays a vital role.
The Challenge of Documenting in the Life Sciences
There are a lot of sectors within the life sciences industry, such as pharmaceuticals, biotech, med-tech, clinical research and diagnostics. Their body of work includes intricate documentation with large amounts of “science-ESE” (scientific words), technical jargon, and regulatory verbiage. To translate such content, it is not enough to be skilled in a language, but domain knowledge and awareness of local regulatory environment is also a must and quality checks are very stringent.
Materials including investigator brochures, informed consent forms, clinical study reports, pharmacological data, and the packaging insert are required to be appropriately translated. Even the slightest slip-up could result in delays to drug approval, loss of credibility or, worse, you could wind up in court.
Why Certified Translation Matters
The certificate of translation – translated This is a statement signed by the translator who did the translation to confirm, that, to the best of his/her knowledge, the translation is true and correct. In the case of regulatory bodies such as the U.S. FDA, the European Medicines Agency (EMA) or Health Canada certified translations are usually required for submission.
Any professional translator or a language service provider (LSP) would have to comply with a range of quality assurance procedures, which is usually several iterations of editing and proofreading by subject-matter experts. They read the target language and know the science, so they can translate even complex terms and regulatory jargon.
Regulatory Compliance Across Borders
Every country has its own regulatory authority, with different languages and document requirements. For example, the EMA mandates documents to be made accessible in the official languages of member states of the European Union, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) expects comprehensive, accurate Japanese translations relating to clinical trials.
A qualified translation service will also guarantee the conformity of a given submission with the linguistic, technical and legal standards applied to the target market. This is expected to speed the approval process, decrease the rejection risk, and shorten the new drug or device time-to-market.
Characteristics of a Trusted Certified Translation Service Provider
All translation services are not the same. For life sciences corporations, it’s important to forge a relationship with the type of LSP that specializes in the field, and that provides certified services. Some features to look for are:
ISO Certification: As for certification, ISO 17100 may offer quality management for translation services also ISO 9001.
Field of Expertise: Translators specialized in medicine, biology, or pharmacology.
Compliance Expertise: Knowledge of regulated standards such as ICH guidelines, SDTM, FDA 21 CFR Part 11, & EU MDR.
Privacy & Security: Strong privacy policies for sensitive and confidential data.
Multi Step Quality Process: Translation, Editing, Proof reading, after proofreading by a second Professional Official Certification.
Conclusion
Qualified life sciences translation services are critical for companies that need to find their way through the maze of international regulatory requirements. They’re the gatekeepers to make sure essential documents pass not just the linguistic muster, but the legal and scientific one as well. By trusting high-quality certified translation, life sciences companies can rapidly expand globally while reducing the risk of non-compliance.