BUILD QUALITY FROM THE START
WITH QUALITY BY DESIGN (QbD)
WITH QUALITY BY DESIGN (QbD)
Quality by Design (QbD) is a systematic framework that integrates statistical analysis, risk management, and data-driven decision-making throughout pharmaceutical development and manufacturing. Its core objective is to identify and control variability by deeply understanding how critical material attributes (CMAs) and process parameters impact product quality, ensuring medicines are consistently safe, critical process parameters (CPPs) effective, and manufactured right from the start. Through tools like multivariate analysis, process analytical technologies (PATs), and knowledge management systems, QbD enables more efficient processes, reduces costly failures, and supports global regulatory compliance.
How Quality by Design (QbD) Drives Success Across the Global Pharmaceutical Development Lifecycle
In a highly competitive and regulated environment, QbD provides pharmaceutical and biotech companies with structured frameworks to accelerate their development, optimize technology transfer and reduce deviations. Aligned with ICH Q14 guidance, it supports the definition of critical quality attributes (CQAs), risk mapping, and the establishment of a robust design space, driving stronger regulatory submissions, improved lifecycle control, and more predictable scale-up across global markets. QbD delivers measurable impact across the development lifecycle:
QbD delivers measurable benefits:
- Efficiency -> Accelerated development timelines through fewer iterations and a clear path to optimization
- Compliance -> Stronger regulatory submissions backed by scientific rationale and risk-based decisions
- Scalability -> Smoother tech transfer and scale-up with fewer surprises between sites and stages
- Flexibility -> Improved lifecycle control with the ability to make post-approval changes within a predefined space
- Quality Assurance and De-risking -> Less rework, fewer deviations, and better long-term resource utilization.
At nuvalore, we apply Quality by Design (QbD) principles to deliver tailored solutions that enhance process understanding, reduce development risks, and accelerate timelines of pharmaceutical development, all while ensuring alignment with global regulatory standards. Our team works closely with you to define critical quality attributes, establish a clear design space, and implement robust control strategies to drive consistent product quality, enable efficient scale-up, minimize deviations, and support smoother regulatory submissions from development through commercialization.
Extending QbD to Analytical Methods: Building Flexibility and Reliability with Analytical Quality by Design (AQbD)
While Quality by Design (QbD) focuses on embedding quality into pharmaceutical products and manufacturing processes from the outset, Analytical Quality by Design (AQbD) applies these same principles to analytical method development, ensuring methods are scientifically rigorous, regulatory-compliant, and resilient across the product lifecycle.
For global organizations managing complex portfolios, AQbD provides the structure needed to scale methods efficiently, reduce analytical variability, and maintain control across multiple sites. By defining a Method Operable Design Region (MODR), a validated range within which method parameters can be adjusted without revalidation, AQbD enables lifecycle adaptability while minimizing regulatory burden. This flexibility helps prevent out-of-specification (OOS) results, where data fall outside predefined limits, and out-of-trend (OOT) events, where results deviate from historical norms despite being within specification. Both of which can disrupt timelines and escalate investigations.
At nuvalore, we provide end-to-end AQbD support, aligning with your objectives and delivering tailored solutions from early feasibility studies to method development, validation, and lifecycle management. We work closely with your teams to:
- Define your Analytical Target Profile (ATP): Establish clear performance criteria aligned with product goals and regulatory expectations, setting a strong foundation for method design.
- Identify Critical Method Parameters (CMPs): Pinpoint variables that influence method performance to enable better control and reduce failure risk across analytical sites.
- Apply risk-based development strategies: Prioritize resources and testing based on scientific risk assessments, ensuring robustness while minimizing unnecessary complexity.
- Establish a robust MODR: Enable flexible method adjustments across the lifecycle without triggering revalidation, supporting tech transfer, post-approval changes, and global consistency.
Partner with nuvalore to transform your analytical methods into strategic assets, build resilient and compliant strategies that reduce risks, enhance performance, and accelerate product development at every stage.
Leveraging DoE to Power QbD and AQbD Strategies
As pharmaceutical development becomes increasingly complex, success hinges on the ability to make data-driven decisions quickly, without compromising quality. Design of Experiments (DoE) is a foundational element of nuvalore’s approach to both Quality by Design (QbD) and Analytical Quality by Design (AQbD), helping teams optimize processes and methods with speed, confidence, and scientific rigor.
- Unlike traditional “One Factor at a Time” (OFAT) approaches which vary a single parameter while keeping others constant, DoE examines multiple variables simultaneously, uncovering critical interactions and delivering insights with fewer experiments.
- Benefits of DoE in pharmaceutical development includes:
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- Faster method optimization through efficient study designs
- Deeper insight into variable interactions and critical factors
- Reduced development costs and resource burden without sacrificing quality
- Stronger regulatory submissions supported by robust data
- Seamless integration with QbD and AQbD strategies
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At nuvalore, we leverage Design of Experiments (DoE) as a strategic tool to drive smarter decision-making, minimize development risk, and strengthen regulatory confidence, from early-phase design through full lifecycle management. Our team collaborates closely with you to integrate DoE into both product development and analytical workflows, ensuring each study delivers actionable insights and uncovers opportunities for optimization and innovation.
Why Leading Pharmaceutical Companies Choose Nuvalore
Leading pharmaceutical and biotech companies trust nuvalore to help them navigate complex pipelines, global operations, and evolving regulatory landscapes. Our integrated QbD, AQbD, and DoE services support organizations that demand scientific precision, cross-functional coordination, and scalable strategies from early development through commercialization.
By partnering with nuvalore, our clients can:
- Reduce development risk through structured, data-driven frameworks
- Improve cross-functional efficiency across R&D, quality, regulatory, and manufacturing
- Align seamlessly with ICH guidelines and global regulatory agency expectations
- Build flexibility into methods and processes without compromising control or compliance
- Accelerate innovation through the application of advanced scientific tools and methodologies
- Receive tailored support with customized strategies that align to your product, platform, and operational needs
- Leverage decades of specialized experience in pharmaceutical analytics and regulatory strategy
Partner with nuvalore to embed quality from the start, design with confidence, develop with control, and deliver with quality.
Frequently Asked Questions about Quality by Design
The core purpose of QbD is to embed quality into the product from the start by understanding how materials and process variables impact performance. It reduces variability, enhances consistency, and enables faster, more predictable, and compliant pharmaceutical development.
Traditional approaches rely on testing the final product to ensure quality. In contrast, Quality by Design (QbD) emphasizes understanding the process and controlling variability from the start. This proactive approach reduces deviations, improves consistency, and streamlines regulatory approval.
AQbD applies QbD principles to analytical method development, ensuring methods are scientifically sound, robust, and adaptable across the product lifecycle. It incorporates risk assessment, method understanding, and design space concepts to reduce variability, support global method transfer, and enable post-approval flexibility.
Design of Experiments (DoE) enables efficient testing of multiple variables at once, quickly identifying critical factors and interactions. It accelerates optimization, improves process control, and strengthens regulatory submissions.
Regulatory agencies like the FDA and EMA strongly support QbD because it demonstrates scientific understanding, process control, and risk management. This leads to more robust, flexible, and confident submissions.
QbD is applicable across product types, including small molecules, biologics, peptides, and advanced therapies. It helps manage complexity, reduce variability, and ensure consistent quality, regardless of molecular format.
nuvalore GmbH
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nuvalore GmbH
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D – 69181 Leimen
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+49 (6224) 179 966 0
