Pharmaceutical Industry Solutions
Maintaining Regulatory Compliance with Professional Content Development
Pharmaceutical companies face a growing list of regulations governing everything from production processes to product labeling and instructions, as set forth by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and Japan's Ministry of Health, Labor and Welfare (MHLW). To sell in these markets, companies must address extensive language requirements — presenting all documentation in up to 14 languages. And they must keep pace 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.
With lives on the line, quality assurance testing is crucial. But pharmaceutical companies must also fully maximize the amount of time their products have full patent protections.
Having an experienced partner with proven pharmaceutical expertise, integrated development and language translation capabilities, and global scale can make all the difference. Lionbridge is helping the world's leading pharmaceutical companies achieve their market objectives with:
- Global clinical trial support with a highly specialized business practice dedicated to Linguistic Validation and Clinical Trial Translation to ensure that the data you use to interpret your trial is clean and conceptually equivalent to the source instrument
- Translation and content development services for the full range of printed and electronic pharmaceutical documentation — from labels to IFUs and package inserts — with consistent quality and accuracy to ensure compliance and to minimize risk
- Application development and maintenance 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; in addition, services to provide robust DW/BI integration to gain deeper insights into company performance, customer trends, and spot future profit opportunities
- Training content translation 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 localization and outsourced services, for markets around the world.