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Quality by Design Services

We've been involved in Quality by Design (QbD) since the 1990's, and today our managing director serves on the Pharma QbD advisory panel.  We can help you speed time to market and lower costs.

 

Cost-Effective, Low Maintenance Solutions

• Specialized, corporate workshop on applying Quality by Design to your business

• Comprehensive, easy-to-follow SOPs, forms and policies

• Audit and gap analysis of Quality by Design implementation across your product portfolio

• Quality by Design program development, implementation, training and assistance

• Process analytical technology (PAT) strategies, assessments and advice

• Incorporation of QbD principles and components into your current SOPs line with regulatory requirements, best practices guidance, and business needs

 

Receive

• Compliance with FDA expectations for Quality by Design - from labs to postmarket

• Adherence to the requirements of ICH standards

• Personalized, individual attention and expert advice from someone who's walked in your shoes

• One full year of support and advice if you're ever audited or inspected

 

Sample Downloads

• Report:  Executive Guide to Understanding Quality by Design  (PDF)

• Article Reprint:  ICH Annex to Q8: Analysis of Quality by Design in Product Development  (PDF)

• Article Reprint:  Elucidation: Quality by Design Lessons from the Auto Industry  (PDF)

• Interview in Automation World:  A Change of Course for Pharma Manufacturing  (PDF)

 

More Resources

• Recorded Seminar & Resource Kit:  Speeding Drug Development with Quality by Design

 

What to Do Next

Contact us today.  We offer a FREE ½ hour consultation to new clients.