Standard practices mitigate risk earlier in product development, and facilitate regulatory compliance and successful outcomes
Our QbD on-demand training course is now available.
Stay ahead of risks and challenges in drug development
Technology, systems thinking, science, and analysis boost productivity and propel your product first to market.
Shorten timelines and increase productivity
Standard practices in each phase ensure you do things right the first time, thereby saving time and money.
Leverage technology to predict outcomes
Tools that enable scientists to conduct advanced predictive modeling without requiring a PhD in statistics
Succeed in Business
Technology, systems thinking, science, and analysis boost productivity and propel your product first to market.
Scientific Expertise
Tight weaving of advanced, yet accessible, predictive analytics with scientific expertise from discovery through to commercialization leaves no gaps.
Contact a solution expert to schedule a free consultation
How can QbD help your company?
Pharmaceutical and biotechnology companies are under increasing pressure to reduce timelines and costs to speed the delivery of safe and high-quality products to patients. Even though timelines change, the activities within the CMC regulatory pathway must be fulfilled and it is essential to look at the CMC program holistically and in early development.
Our offerings stem from a methodology that blends delivery of focused, hands-on training, deep expertise in process development and commercialization, CMC strategy and FDA interactions, and integrated analytical applications. We combine our offerings in various configurations to standardize our clients’ work to the extent possible while providing flexibility to best respond to unforeseen situations as they arise.
Phase-Appropriate Quality by Design (QbD) is a systems approach to drug development and manufacturing that mitigates risk and facilitates regulatory compliance and successful outcomes.
Getting started
Harness a phase-appropriate QbD strategy to stay ahead of risks and challenges in drug development
Option 1: Resolve a current issue
Let’s talk about how we can resolve it and improve your development or production issue.
Option 2: Explore immersive training
Consider our hands-on, QbD training course specifically developed for pharmaceutical and biotech companies.
Option 3: Adopt a modern strategy for drug development
Build a roadmap for success. Modernize process characterization by integrating validation processes, data visualization and analysis, and regulatory compliance.
Contact a solution expert to schedule a free consultation
View a customer success story to learn more about how QbD helped to resolve a company’s business challenge.
Explore how QbD boosts higher quality and continuous improvement in earlier stages of process development towards bringing new products to market faster.
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