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Industry Booklets

 

An Executive's Guide to Quality by Design This short report offers a review of the top techniques of the FDA's Quality by Design for biopharmaceutical and medical device executives.  Developed with FDA Expert Briefings, the guide overviews Quality by Design concepts from preclinical to postmarket. Download your complimentary copy of An Executive's Guide to Quality by Design.  (PDF, 223kb)

Is Quality by Design Right for My Organization...? Bringing a new regulated product to market typically takes at least 10 years and more than $802M.  Filled with facts, questions to answer plus an innovative starting blueprint of five tactics to increase your time to market speed and reduce your costs by 12%, this 36-page workbook is designed to help you assess if Quality by Design is appropriate for your company now or if you should wait until the FDA and the industry are more in synch. Retail cost:  $14.95 (USD) Quantity discounts and company personalization are available. Send an e-mail for quote. To order the workbook, please send an e-mail with your contact details to booklet [at] ceruleanllc.com (be sure to specify you'd like the QbD workbook) OR fill out our booklet request form.  We will send the invoice along with the booklet. A free PDF extract is available for download. (811kb)

Ten Ways to Control Compliance Costs If you're struggling to contain the cost of regulatory compliance, you're not alone.  Cost-effective compliance is a core component of global competitiveness.  This 18-page booklet, filled with examples and case study results, provides ten concrete steps to get your costs under control today. Retail cost:  $16.95 (USD) Quantity discounts and company personalization are available.  Send an e-mail for quote. To order the booklet, please send an e-mail with your contact details to booklet [at] ceruleanllc.com (be sure to specify which booklet you'd like) OR fill out our booklet request form.  We will send the invoice along with the booklet. A free PDF extract is available for download. (852kb)

 

 

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