Industry survey reveals that risk assessments take about 3 months.
3 MONTHS?! As busy scientists, we can't afford 3 months of group meetings.
Meet Lean QbD™ - Risk Assessment in 3 Days
Powered by our software and infused with proven best practices
Turn QbD skeptics into supporters.
And with Lean QbD™ Templates, you can begin instantly.
Risk assessment is the first and the most important step in QbD. Do it right the first time.
Cut 3 months of meetings to 3 days. How much is that worth? $15M for your company.
We did the hard work so you don't have to. Jump start with
Lean QbD™ Templates.
Need a hand? We are here for you. Your QbD success is our mission. Consulting available.
Best Practices of QbD Risk Assessment has been designed into the software.
No Learning Curve.
New Video Coming Soon!
Don't work harder. Work smarter.
Lean QbD™ is the only QbD Risk Assessment tool that connects process parameters to your patients.
Using Correlation Matrix and FMEA to calculate the risk of Quality Target Product Profile, Critical Quality Attributes, Critical Process Parameters and Critical Material Attributes, the patent-pending algorithm works in the background so you can focus on what's important - connecting science to patients.
FDA, EMA reviewers use risk assessement as the executive summary in the CMC (Chemistry, Manufacturing, and Controls) section of New Drug Application submissions.
Quality by Design submission is now the new standard of our industry.
Risk assessment is the 1st step in QbD and first impression matters. To succeed in your QbD initiative, get risk assessment right - the first time. Don't make it painful.
Provide a positive experience and show practical results with Lean QbD™
QbD risk assessment prioritizes which Design Space studies your team should work on first. With limited time and resources, prioritization is critical.
Risk assessment links design space to your Lifecycle Control Strategy.
No need to Re-invent the wheel. Shortcut the learning curve. Our process development scientists crafted LeanQbD™ Templates based on industry and FDA case studies. If you'd like a custom template for your product, please contact us.
If you are asking the questions below, you are on the right track.
Click the button below to try LeanQbD and see how Lean QbD™ will help your QbD projects succeed and turn skeptics into believers.