
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…
Innovative biotech products present a complex regulatory environment. For this reason, a formidable regulatory strategist is a critical member of the…
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…
This white paper provides biotech companies an overview of the considerations for Chemistry, Manufacturing and Controls (CMC) in asset development.…
A substantial change to the drug development landscape is currently underway. Regulatory authorities are starting to acknowledge pediatrics as one of…
Rare disease is a complicated but rewarding space for drug developers of all sizes. Most rare diseases have no approved treatment options, making…
Delivering drugs to the patients who need them can be an increasingly complex, time-consuming, and costly undertaking, particularly for smaller…
PRA has experience partnering with small biotech firms, and we understand that they require a different approach than larger pharmaceutical…
Emerging biotech companies are a significant and burgeoning sector of the pharmaceutical development market. These companies may require unique and…
PRA understands the pressures emerging biotech companies face. We resource client studies with team leads that remain for the duration of the study…
Biotech is in our DNA. PRA has recognized the importance of emerging biopharma since our humble beginnings, when we first started partnering with…