Solutions

Case Studies: Practical Solutions to our clients most challenging business problems.

The following case studies detail specific challenges we’ve overcome, the practical solutions we recommended, and the results delivered. Each success story will be part of a growing library of diverse case studies illustrating practical solutions to our clients’ challenging regulatory compliance and quality-related problems.

• • When You Expect the Unexpected, Call PSG for Help!

• • Savings of over $100K in 3.5 hours

• • Making Lemonade out of Lemons

• • Taking Risk out of REMS

• • Out of the Clouds

• • A Business Deal Savior

• • Was the Safety System an Adverse Event?

• • Building a cGMP Quality System as a Growth Strategy

• • Right on the Money

• • Giving Luck a Chance

• • Touchdown

• • “Practical” does not always mean “Cheaper” or “Faster”

• • Finding a Needle in a Haystack

• • To the Rescue … Quickly

• • One Size Does Not Fit All

• • What’s in a Name?

• • Visiting Australia Would Have Been Nice, but …

• • ISO Certified? So What?

• • Don’t Try This at Home: If You are Not Expert in a Particular Operational Area, You Need an Expert to Help You Out

• • Practical Operational Solutions to an Impractical Regulatory Approach

• • What Will Practical Knowledge of Industry Operations and QA Buy You?

• • A Practical Road Map: Zero to 60 in Four Days

• • Regulatory Compliance Simplified

• • Practical Tips and Practical Guidance Leads to Efficient Process

• • A Real Practical Business Solution

• • Practical Savings

• • The Devil Was Really in the Details

• • A standard Two-Day Regulatory Audit at a Client’s Vendor Turned Out to be a Lot More

• • Practical Moves for Practical People, with Assistance from The Practical Solutions Group, LLC

• • Building Up Client’s Quality Infrastructure—Building Up Client’s Confidence in their Ability to Meet Industry’s Expectations

• • Identify a Practical Approach to Compensate for a System Improperly Developed and Validated

• • Completing the Qualification of a Major Upgrade of a SAS Installation. Impediments Overcome. Everyone Comes Out a Winner.

• • Ensuring the Validity and Accuracy of Data Intended for FDA Submission and Helping to Improve Quality of CRO’s Operations. All in a Day’s Work.

• • Practical Regulatory Compliance Audit Minimizes Legal Business Risk

• • Ready for Prime Time?