In recent months, I’ve engaged in extensive consultations with clients on diverse aspects of life sciences localization. My focus has been on a quartet of critical areas: language and content technology, quality assurance, regulatory compliance, and operational efficiency within the existing regulatory framework.
Life Sciences Localization Challenges
This journey has unveiled five principal themes, presenting unique challenges to both customers and Language Service Providers (LSPs) who are navigating the complexities of this regulatory landscape:
- Fostering a Culture of Quality and Transparency: Achieving a seamless partnership that emphasizes quality and transparency can significantly impact the success of bringing medical devices, pharmaceuticals, and biotechnology products to international markets. We’ll explore the importance of establishing such a culture and offer strategies for both life sciences companies and LSPs to foster this critical collaboration.
- Regulatory Environment Evolution: We will examine the shifts in the regulatory landscape today compared to five years ago, and the distinctive challenges these changes have introduced.
- Efficient, Value-Driven Content and Localization Workflow Design: We’ll do a deep dive into how to craft and implement workflows and programs that are both efficient and value-oriented, tailored to meet the demands of the current regulatory context.
- AI in Localization: The integration of AI into life sciences localization is often met with resistance and more questions than answers. We’ll bring insights to AI’s role in life sciences localization and best practices for seamlessly integrating AI into your processes. These steps enable you to reduce time to market, while ensuring full compliance with regulations.
- Comprehensive KPI Framework for Continuous Improvement: Establishing a robust framework for Key Performance Indicators (KPIs) enables clients and LSPs to drive ongoing improvement. Many of the KPI’s used for life sciences localization today have been in place for 20+ years, and do not all align with current business objectives. We’ll discuss how to best define and structure these frameworks and how to use measurable translation quality as a tool for success.
Sector-Specific Challenges
Additionally, there are sector-specific challenges within the life sciences field that warrant special attention. These include:
- Navigating FDA translation validation requirements effectively.
- Understanding the impact of clinical trials regulations on the localization lifecycle.
- Adapting to the volume and timing challenges introduced by the recent Medical Device Regulations.
- Addressing the requirements of 21 CFR Part 11 in translation management and other language technologies.
- Ensuring data security for digital life sciences products.
Over the next 2-3 months, I’ll delve into these topics through a weekly series of blog posts. If there are other core life sciences localization challenges you’re facing that you would like to see covered, please feel free to comment or contact me directly.
Sonia brings 30+ years of leadership experience in the localization industry. Having worked with a diverse range of clients and industries, Sonia brings a wealth of knowledge and a proven track record of success in delivering exceptional localization solutions.