A systems approach to drug development and manufacturing

Standard practices mitigate risk and facilitate regulatory compliance and successful outcomes.

New! On-Demand QbD Training

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.

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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.

Stay ahead of risks and challenges in drug development while boosting productivity and reducing costs

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

Schedule a Demo

View a customer success story to learn more about how QbD resolved a company’s business challenge.

See how your company can boost productivity and propel your product first to market.

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