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thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

Life Science Consulting Pre-Approval Inspection

June 23, 2020

6 Tips for Evaluating Your CMO’s PAI Readiness

The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...

Life Science Consulting Pre-Approval Inspection

June 18, 2020

Conducting a PAI Mock Inspection: How to Execute and Evaluate Your Findings

Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare. Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval...

Life Science Consulting Pre-Approval Inspection

June 15, 2020

Pre-Approval Inspection (PAI): What it is and How to Prepare

What is a Pre-Approval Inspection (PAI)? A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug...

Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.