Translation and localization systems have become a competitive advantage for global manufacturers of medical device, pharmaceutical, biotechnology, and healthcare products. ENLASO partners with life sciences companies to cost-effectively market products globally in compliance with international regulatory language requirements. Delivering quality translations, ENLASO simplifies language processes, reduces project costs, and enables faster time-to-market.
Managing languages and international regulatory affairs are among the most critical aspects of developing and marketing products for the global life sciences industry. Any mistake, no matter how minor, can delay product approvals, launches, or cause widespread public relations disasters. ENLASO specializes in language solutions for the life sciences industry, providing accurate and consistent translation and localization services that enable customers to focus on their core competencies.
Specialized Language Resources
ENLASO translators and editors are formally educated native speakers with extensive industry experience and backgrounds in medical, pharmaceutical and biotechnology. With an integrated network of offices and global linguistic partnerships, ENLASO ensures success at every stage of your localization project: from regulatory documentation to large user manuals; device GUIs to marketing communications. The technical accuracy and consistency of ENLASO’s linguistic experts are complemented and leveraged by the effective use of language technologies, translation memories, and terminology glossary management systems.
ISO 9001 Certified Language Services
ENLASO is an ISO 9001 certified language services provider with documented quality and customer service processes. With stringent methodologies at every organizational level and project milestone, ISO 9001 certification recognizes ENLASO's rigorous linguistic selection process, employee training, customer-focused account and project management, and customer service practices.
We are literally a part of your team. In the eyes of international regulatory bodies, ENLASO's ISO 9001 certified processes are equivalent to having an in-house translation and localization department.
Global Regulatory Language Services
Releasing medical products domestically traditionally takes years to complete. Global releases can take even more time due to unique country-specific and regional compliance requirements.
ENLASO provides unparalleled multilingual regulatory expertise, empowering manufacturers of life sciences products to cost-effectively market their products worldwide with regulatory compliance in every market. ENLASO’s ISO 9001 certification shortens lengthy regulatory approval cycles and facilitates simultaneous entry into multiple target markets while reducing the impact on internal resources.
CE Mark Specialization
Estimated at 30% of the global medical device market, the European Union currently requires that all product information be in the official language of the local users. ENLASO has extensive experience with the MDD, IVDD, AMDD, GMP, 510(k), and other international regulations as well as being a CE Mark specialist. Leveraging extensive experience advising clients to achieve successful regulatory compliance, ENLASO has the resources and knowledge to successfully localize all relevant assets for all medical device classes.
Life Sciences Enterprise Language Partner
ENLASO is committed to exceeding customer expectations as your enterprise language partner. Long-term global success in the life sciences industry requires a dynamic language partner – one that establishes technical, organizational, and process standards early. Led by a flexible team of language professionals and localization consultants, ENLASO optimizes your localization capabilities and empowers you to develop your global markets.
ENLASO’s internationally recognized language experts actively participate in the development of industry standards to benefit both the customer and the technologies used, improving localization processes worldwide. Today, ENLASO is actively involved with RAPS (Regulatory Affairs Professionals Society), STC (Society of Technical Communications), GALA (Globalization and Localization Association), OASIS (Organization promoting the advancement of XML), ATA (American Translators Association), and the W3C (World Wide Web Consortium).