|
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. |
|
|
Industry
Leadership
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).
|
|
|
|
|
|
|
