In today’s global market, an understanding of complex international laws and standards is a must. For example, packaging and labeling requirements can restrict the way your products may be introduced in international markets. Idea Translations helps clients develop strategies to effectively comply with these regulatory requirements.
Whether it is a medical device, a clinical trial or information about a pharmaceutical product, it is important that regulatory content is clear and follows the requirements established by the government entity of each target market.
A fast-pacing world, where regulations change so frequently, puts a great pressure on regulatory professionals and translating content is more difficult and more demanding. Requirements often need to be completed quickly as approval to market a product depends on this. Nevertheless, keeping quality in mind, translation problems can lead the regulatory entity to question some information which slows the approval process. The best approach is to spend time in QA before submission to avoid delays later on.
Idea Translations specializes in life sciences content and has subject-matter experts with skills and experience to assist partners such as Cochlear, Bristol Myers-Squibb, Merck, Merit Medical, Huntington Hospital and others.
Here are some translation tips you have to keep in mind:
- Avoid the use of non-critical content. Make sure you understand the requirements from the local regulatory institution and avoid over pampering the content. Stick to what’s required.
- The format of content is as important as the content itself. Very often, changes in protocols and documents require stringent identification of changes as well as versions. This often involves changes in graphs and charts that are key to regulatory authorities to determine the scope of the changes.
- It is important to have a secure storage solution for the content that is capable to identify dates of uploads, changes as well as version names. These are critical for regulatory content.
- Make sure your translation solution provider is able to provide (and grant you the rights to) translation memories and glossaries, as these will be key assets to reduce costs as well as keeping consistency of terms.
Finally, most regulatory content will be submitted in the form of Ms Word and PDF. Your selected provider must be an advanced expert in these words processing tools, otherwise you might run into formatting issues that can cause delays on the submission of the content. DTP often provides proof of efficacy in the form of tables with data, charts, graphs and similar. This data structure, when translated, requires the expertise of a graphic designers familiar with tools to edit them.
Regulatory content is confidential as it contains extensive information related to trials and processes that might be trade secrets of the company requesting approval. It is key to have a partner who is able to store the content securely and have a data security policy in place.