By identifying the proper product category, we worked with an international company to correctly reposition its drug-device combination product for FDA approval and drive market penetration.
Throughout the lifecycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct… Regulatory pathway, FDA center, Key Opinion Leaders (KOLs), Target Product Profile (TPP) inclusions, Data to rely on, Studies to conduct, Indication and
By identifying the proper product category, we worked with an international company to correctly reposition its drug-device combination product for FDA approval and drive market penetration.
When a biotech company could not afford the time and expense to conduct intended studies, we stepped in and quickly and creatively turned things around with the FDA.
Premier Consulting selected CROs to run the multi-species genotoxicity program within the FDA’s agreed-upon timelines.
With strategic submission support, a biotech company gained approval for an improved delivery technology of an already-approved drug, setting the potential to become a new “gold standard” treatment in oncology.
