Life Sciences Translation and Localization Experience

MedL10N is a dedicated Life Sciences division at CSOFT International with an undivided focus on delivering quality translation and localization services to organizations in the Life Sciences industry. We are the first Asia-based translation practice to have earned ISO 13485:2003 certification, and one of the only multilingual localization vendors to be accredited with both ISO 13485:2003 and ISO 9001:2008 certifications worldwide.

Effective localization in the Life Sciences (LS) industry requires mature quality processes structured around a defined, traceable workflow. Beyond that, relevant domain knowledge coupled with an extensive background in multilingual localization is the key to the ongoing satisfaction of our clientele.

At MedL10N, our senior management has over 25 years of direct, operative experience in Life Sciences localization. This extends to all aspects of the product development cycle, from patent filing to post-marketing approval, so you can rest assured that we understand the unique localization challenges that companies face on a daily basis.

From regulatory compliance, to labeling, patent applications and file distribution, we are intimately familiar with highly regulated workflows, and respect the importance of our role in your international product release cycle. MedL10N is dedicated to working within your distinct boundaries to meet your deadlines and unique budgetary objectives.

Specifically, we deliver full-service localization solutions in more than 90 languages to organizations in the following sectors of the Life Sciences industry:

• Pharmaceutical Firms
• Medical Device Manufacturers
• Biotech Companies
• In-Vitro Diagnostics Manufacturers
• Contract Research Organizations (CROs)
• Imaging Manufacturers
• Biopharmaceutical Suppliers

Some of our better-known clients in these domains include GlaxoSmithKline, Pfizer, Medtronic, GE Healthcare, Beckman Coulter, Bio-Rad, Carestream Health, Waters, BIOTRONIK and Varian.

In addition, our clients in the Life Sciences industry benefit from our proven experience with the following regulatory and risk management standards:

• Compliance with the European Union Directives
• In Vitro Diagnostic Medical Device Directive 98/79/EEC (IVDD)
• Active Implantable Medical Device Directive 90/385/EEC (AIMDD)
• Medical Device Directive 93/42/EEC (MDD)
• Directive 2004/27/EC (human medicines)

In CSOFT’s MedL10N division, we seek to redefine localization for the Life Sciences by combining industry-specific best practices, exacting standards, and accurate translation with traceable quality metrics and best-of-breed technology. We only employ in-country translators with subject-matter expertise, and a minimum of seven years’ translation experience in medical and clinical-research fields.

Life Sciences translations are filled with industry-specific terms that are often complex and do not always have an equivalent in the target language. For that reason, it is essential that translators understand the context, the audience, the discipline, and the culture of the end user. 

At CSOFT, by applying the above standards to our pool of pre-qualified translators who are categorized by subject-matter-expertise, we can provide translation services for the following:

• Clinical Documentations (Informed Content Form, Clinical Reports)
• Linguistic Validation (PRO and e-PRO)
• Regulatory Documentation (Compliance and Dossier)
• Labeling and Package Inserts (including multi-ply layout and design)
• Patents and Legal Documents
• User Assistance Documentation (Help, Instructions for Use)
• Scientific and Medical articles
• Marketing Communications
• Training and e-Learning
• Financial Documents

Representative Life Sciences clients include: