Biotech Localization and Process Optimization

Ensuring Quality with Professional Process and Content Development Services

Like pharmaceutical companies, biotech companies face a growing list of regulations governing everything from production processes to product labeling and instructions — specific to each global market. Even when selling in a single market, companies must disseminate product information in multiple languages. (EMEA, the European Medicines Agency, requires all materials in 14 languages.)

Biotech companies must also comply with new format regulations, such as the FDA's 21 CFR Part II governing electronic records and Structured Product Labeling (SPL), requiring labeling in XML format. In addition, they must meet industry standards, such as GxP, ensuring traceability and accountability in production processes and systems.

Ensuring quality and accuracy is crucial. But companies must also accelerate their time-to-market, with any delay in launching potentially costing tens of millions in lost revenue.

Having an experienced partner with proven biotech expertise, integrated development and language translation capabilities, and global scale can make all the difference. Lionbridge is helping the world's leading biotech companies achieve their market objectives with:

• Translation and content development services that leverage our biotech domain expertise to deliver printed and electronic documentation with consistent quality and accuracy across multiple languages to ensure compliance and to minimize risk
• Application development and testing services, including integration of back-end and customer facing systems and data migration/conversion, to help ensure compliance with production systems' validation requirements, including IQOQPQ
• Process optimization services to help companies streamline their processes for launching products in global markets, accelerating time-to-market and increasing efficiency
• Training localization services for product users in their native language to ensure appropriate product use, and for sales representatives to accelerate training and enhance sales success

Lionbridge provides the scalability to launch products in multiple global markets simultaneously, without increasing the burden on in-house staff. And we reduce cost and complexity by providing a single, flexible source for a wide range of content and technology localization services, for markets around the world.