Tagged: Product Development Planning
BBCR offers expertise in the areas of Product Development Planning and Validation or Qualification when biomarkers are a part of your product development plan.
October 26th, 2021 | Product Development PlanningIdentification and adoption of biomarkers are especially valuable in rare disease and precision medicine product development. Learn more about how BBCR can help.
February 9th, 2021 | Product Development Planning
Biomarkers are now a routine part of drug development The FDA recognizes biomarker development as a high priority area for future research. The FDA and European Medicines Agency (EMA) have developed similar processes for the qualification of biomarkers intended for use as companion diagnostics or for development and regulatory approval of a drug or therapeutic. […]