PPD Provides Rapid and Accurate Bioanalysis

Case Study

A large and successful generic drug manufacturer requested bioanalytical support for an ANDA submission. Our rapid and accurate analysis of pilot and pivotal study samples provided data to guide critical decisions in their product development program resulting in timely submission and fast regulatory agency approval.

The sponsor was so pleased with the service they received that they selected PPD as their primary provider for bioanalytical studies. Over the following months they relied on PPD to support nine more successful ANDA submissions, based on our ability to:

• Consistently deliver reliable data on time
• Provide accurate and detailed timelines to facilitate manufacturing and quality assurance/quality control planning
• Quickly respond to schedule adjustments necessitated by changes in study timing and scope