Quality Regulatory Translation Services for Global Compliance
Questel offers comprehensive regulatory translation services to help simplify the international compliance process. Clients rely on us to ensure accurate, on-time submissions as well as the delivery of safe products to end-users around the globe. They expect translations that are linguistically accurate and comply with all local and cultural requirements, that’s why our commitment to quality is unwavering. Questel has over 20 years of experience helping global drug and device companies overcome regulatory hurdles, preparing their documentation for regulatory bodies around the world including the FDA, EMA, CFDA, SFDA, and PMDA.
Common regulatory materials we translate include:
- Instructions for Use (IFUs)
- Labeling (Traditional & eLabeling)
- Packaging Information Leaflets (PILs)
- Validation documents
- Summary of Product Characteristics (SmPC)
- Investigator’s Brochures
- Software Strings
- Validation Documents
Decades of Global Regulatory Expertise
In the ever-changing regulatory landscape, Questel's Life Science Team has subject matter expertise in a range of therapeutic fields and in-depth knowledge of international regulatory requirements. Whether it’s labeling, CE marking, 510(k) submissions or the latest MDR revisions, Questel’s life science specialists have the knowledge and expertise to help you obtain regulatory approval in critical markets around the globe.
Our subject matter expertise is just part of our unwavering commitment to quality. Our quality processes span every stage of the product lifecycle, from patent to post-market, with ISO 13485, 17100 and 9001-backed controls. Our linguists are rigorously vetted and have in-depth knowledge of terminology and nomenclature, which helps minimize non-conformances and ensure accurate translations.
Technology that enables
Questel employs industry-leading technologies to lower costs, improve quality, and enhance the customer experience. Translation memory (TM) tools, for example, leverage previous translation projects to speed up delivery, ensure consistency and lower costs. We also make it easy for you to manage your projects through our secure client platform, where you can get quotes, submit new projects, and download completed translations at your convenience.
Get in touch with one of our experts for a free consultation.