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The Center for Global Drug Development
PRA’s Center for Global Drug Development assists clients in the design and execution of global drug development and asset management strategies. Our…
All Results
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White Paper
Regulatory Considerations for Biotech
Innovative biotech products present a complex regulatory environment. For this reason, a formidable regulatory strategist is a critical member of the…
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Customized Solutions for Biotech
PRA understands the pressures emerging biotech companies face. We resource client studies with team leads that remain for the duration of the study…
Blog
Are We There Yet? - Beyond the Target Product Profile
In the previous blog, we looked at the concept of the Target Product Profile (TPP). At one level, the TPP can be thought of as a document that sets…
White Paper
Chemistry, Manufacturing, and Controls (CMC) in Drug Development and Life Cycle Management
This white paper provides biotech companies an overview of the considerations for Chemistry, Manufacturing and Controls (CMC) in asset development.…
Blog
Demystifying Pediatric Clinical Research for Emerging Biotech
A substantial change to the drug development landscape is currently underway. Regulatory authorities are starting to acknowledge pediatrics as one of…
Blog
5 Questions Small Biotech Should Ask Their Rare Disease Development Partner
Rare disease is a complicated but rewarding space for drug developers of all sizes. Most rare diseases have no approved treatment options, making…
Blog
Much More Than a Single Clinical Trial
Delivering drugs to the patients who need them can be an increasingly complex, time-consuming, and costly undertaking, particularly for smaller…
Case Study
Small Biotechnology Partnerships – A Success Story
PRA has experience partnering with small biotech firms, and we understand that they require a different approach than larger pharmaceutical…
White Paper
Biotech and Early Engagement Considerations: What Companies Must Consider When Developing an Asset
Emerging biotech companies are a significant and burgeoning sector of the pharmaceutical development market. These companies may require unique and…