Good stories
A leading pharmaceutical company partnered with us to solve a persistent challenge: their Quality by Design (QbD) projects, especially for legacy products and technology transfers, were taking over 42 weeks to complete. With responsibility for QbD recently shifted to a new department, the need for a transparent, standardized, and scalable approach became essential. In collaboration with the client, Emendo developed a robust QbD template and toolkit that reduced QbD lead times by 80%, resulting in a 32-week reduction in time-to-market for technology transfer projects while enhancing consistency and embedding ICH Q8–Q12 regulatory expectations directly into the process.
THE CHALLENGE
The client needed to transform their QbD approach to be fit for purpose for legacy products and technology transfer (TT) projects. With timelines averaging 42+ weeks, and no clear process of ownership or structure, projects were difficult to manage and replicate.
The goal was to create a template for products already on the market, enabling faster execution of QbD documentation and regulatory submissions. This standardization was crucial for accelerating timelines, ensuring consistency across projects, and supporting compliance with ICH Q10 (Pharmaceutical Quality System) principles for continuous improvement.
OUR APPROACH
To create a solution fit for legacy and tech transfer projects, we followed a structured methodology centered on understanding the current state, applying relevant insights, and co-developing practical tools with the client. Our “Observe – Think – Improve” approach ensured the final solution was grounded in real needs and shaped by continuous feedback.
Our Tech Transfer experts were also engaged to ensure the toolkit was fully aligned with real-world transfer challenges and in compliance with ICH Q10 (Pharmaceutical Quality System) and ICH Q12 (Lifecycle Management). Our expertise in strategy design, CMO selection, and execution of Tech Transfer projects made the solution practical, scalable, and seamlessly integrated with the client’s wider transfer frameworks.
Learn more about our Tech Transfer services.
Additionally, training was an essential part of the rollout, ensuring project managers were confident in applying the new standard across future QbD efforts.
the result
Through this collaboration, we delivered a comprehensive solution that addressed the client’s needs for speed, clarity, and compliance in QbD projects:
The new setup successfully reduced QbD project lead times from +42 weeks to under 10 weeks (80% reduction), resulting in a 32-week reduction in time-to-market for overall technology transfer projects while improving readiness for regulatory submissions. Today, the QbD project handbook and tool are embedded in the client’s organization and serve as a core component in QbD projects, directly supporting compliance with ICH guidelines while driving speed and transparency in a highly regulated environment.
Importantly, this solution also serves as a powerful supplement to our broader Tech Transfer services, where our experts support clients with strategies, CMO selection, and execution of technology transfer projects. Together, these services create a holistic framework that enables both efficient execution and sustainable long-term success.
Keen to learn more?
A standardized approach to Quality by Design isn’t just about efficiency – it’s about ensuring compliance with ICH best practices, reducing lead times, and creating repeatable success in a regulated environment.
Reach out to Emil Holm Kristiansen to explore how a tailored QbD process can drive faster project delivery, better alignment, and audit-ready documentation across your organization.
Learn more about how we support clients with Tech Transfer strategy, CMO selection, and execution support – and how this QbD approach strengthens and accelerates the process.
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