MedPharm has been named the winner in the Analysis, Testing, and Quality Control category at the prestigious CPhI Pharma Awards 2019.
The annual awards provide recognition to those who turn inspiration into innovation within the pharmaceutical industry.
MedPharm’s win comes as a direct result of its efforts in pioneering and refining new approaches to demonstrate the bioequivalence of topical generic products in regulatory submissions.
“This award is a testament to MedPharm’s depth of experience and integrity in the field of in vitro modeling and topical formulation development,” Eugene Ciolfi, President and CEO of MedPharm, said. “By refining and automating these in vitro models MedPharm has created a cost-effective route to demonstrating bioequivalence.”
Both the EMEA and FDA have recently recognized that the approval of topical generic products has been hampered by their demand to demonstrate bioequivalence in the clinic.
MedPharm has worked with the regulatory authorities to develop in vitro models and robust statistical justification using multiple donors to demonstrate bioequivalence.