• Gustavo Lecomte

Why is Working With an Experienced Packaging and Labeling Translation Service Important?

An Effective Life Science Packaging and Labeling Translation Service Gets Your Product In-country Faster

Life science packaging and labeling translation requires a specific process because most life science packaging and labeling is required to conform to very detailed regulatory guidelines for distribution approval. Each country that the packaging and labeling translation is being distributed in, may also have their own unique guidelines. Working with a life science packaging and labeling translation service that understands these regulatory guidelines, and can receive your original artwork and send back conforming translated content, will streamline your entire process and allow your product to be in-country as quickly as possible.

What are the key steps in the packaging and labeling translation process?

  1. Translation / QA - Packaging and labeling translation needs to be done by professional human linguists who are native speakers of the target language, and who have a proven subject-matter expertise. Packaging and labeling translation is different from other types of translation in that the final output needs to conform to several different requirements, both from a layout perspective and a regulatory perspective. It helps to work with a packaging and labeling translation service that conforms to a documented quality management process. For example, Language Intelligence is certified to the ISO 9001:2015 Quality Standard. Read more about our Quality Management Process.

  2. Client Review - Most packaging and labeling translation projects include a client-side review of the translations, as most of the companies that are working with translation are global organizations that have bilingual in-country staff. This is a powerful QA step, but also a potentially complicated one to coordinate and run effectively. Working with a translation service that has experience coordinating this step is important, because if not run effectively this step can cause the most significant delays and rework. It also helps if your translation service has tools and technology to aid in the review process. Language Intelligence has developed a tool called intellireview™ to manage translation review, and make the process seamless for the in-country reviewer. You can read more about intellireview™ and what it brings to the process here.

  3. Layout - This is the step that is the most critical, and where an experienced packaging and labeling translation service can really differentiate itself from its competitors. The precision that’s required to adapt package inserts, directions for use (DFU) and instructions for use (IFU), labeling, and packaging, into other languages, is a true skill. Particularly when working in double-byte (Chinese, Japanese) and right-to-left (Arabic, Hebrew) languages. If your translation service can handle the complex layout step, and return you back files that are ready for distribution, that puts you way ahead of the game.

Pending Regulations are Driving an Increased Need to Develop a Streamlined Packaging and Labeling Translation Process (The EU MDR Directive)

The requirements of the EU MDR directive, while delayed by Covid, are still pending, with a current anticipated compliance date of May 26th, 2021. Many companies whose packaging and labeling teams are dealing with these pending deadlines are still scrambling to put a process in place to handle the language requirements of the directive. Translation is front and center in the directive with the implications of non-compliance being that your company’s product will no longer be able to be sold in-country until the language requirements of the directive have been met. Regulatory and packaging and labeling groups that are aware of these pending deadlines are working diligently to put partnerships with translation services in place. By prioritizing the service aspects we’ve detailed above, the companies that select the translation services with these services to work with will be well on their way to meeting these requirements on time and keeping their product distribution network running smoothly and without delay.

If you’re interested in learning more about how Language Intelligence works with our customers to help them streamline their packaging and labeling translation process please contact us today.