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Found 59 results for label/Opini.
Regulatory Affairs for FSP
PPD FSP regulatory affairs solutions help navigate regulatory approval and market access with comprehensive end-to-end regulatory services.
Real-World Data’s Role in Solving for Diversity in Clinical Research
Learn how using RWD and RWE to supplement trials provides understanding of safety and efficacy and effective off-label use.
Regulatory Insights: Flexible Regulatory Pathways Accelerating Access to COVID-19 Treatments
In this blog post, John Joines, senior manager of regulatory intelligence, policy and advocacy, and Christina Cocciardo, director of regulatory affairs, discuss some of the flexible and emergency use regulatory pathways facilitating fast-track access to potential or promising new COVID-19 medicines around the world. A recent post focused on similar pathways available in the U.S.
Nephrology and Renal Diseases
In-depth clinical trial expertise in nephrology and renal disease.
Peri and Post-Approval
Biopharmaceutical companies are needing more and more evidence to prove value and effectiveness in post-approval settings, including how to communicate this evidence to payers, health authorities and other decision-makers.
GMP Lab Capabilities
Learn more about the capabilities PPD Laboratory Services’ GMP lab offers to meet customers’ needs from cell-based assays to stability testing.
Regulatory Insights: Regulatory Intelligence Informs Sound Clinical Trial Strategy
Discover how Regulatory Intelligence is used in the pharmaceutical product development process through helping to formulate clinical trial success.
Devices/Diagnostics: Emergency Use Authorizations During the COVID-19 Pandemic
Learn more about the increased uptake of Emergency Use Authorizations (EUA) for medical devices during the COVID-19 pandemic.
Key Considerations for Successfully Planning a Submission
Learn the importance of strategy formulation and regulatory engagement for planning a successful ISS/ISE submission.