Dr. Roseita Esfand is a Principal Consultant at CardioMed Device Consultants, bringing more than 20 years of experience in pharmaceutical development, drug delivery technologies, combination products, and regulatory affairs. She specializes in complex drug-device combination products, providing scientific, technical, and regulatory expertise to help manufacturers navigate product development, manufacturing scale-up, and regulatory approval in the United States and international markets.
Experience
Dr. Esfand has extensive experience in the research, development, and commercialization of medical devices and pharmaceutical products, including injectable, oral, and transdermal drug delivery systems. Her expertise includes formulation development, drug-device combination products, and advanced dendrimer and polymer-based technologies for oncology, antimicrobial, and anti-inflammatory therapies.
Throughout her career, she has led multidisciplinary teams in product development, manufacturing, quality assurance, and regulatory compliance. She has supported technology transfer, manufacturing scale-up, and successful regulatory approvals in the United States and European Union.
Dr. Esfand has held scientific leadership positions at SmithKline Beecham (UK), Dendritech and Dendrimer Nanotechnology (US), Strapharma and PanBio (Australia), and IBI (Canada). She has also advised biotechnology startups on scientific, regulatory, and manufacturing strategies.