Eric Langer
Eric Langer is a member of Pharmaceutical TEchnology's editorial advisory board.
Mr. Eric Langer
President and Managing Partner
BioPlan Associates
Eric Langer is president and managing partner of BioPlan Associates (Rockville, MD), a biotechnology and life-sciences marketing company that provides information, market research, pricing, and market analysis to biotechnology and healthcare organizations. Eric cofounded BioPlan Associates in 1989.
He has more than 20 years of experience in biotechnology and life-sciences international marketing, management, market assessment, and publishing, which includes senior management and marketing positions at biopharmaceutical supply companies. He has launched and managed marketing programs for product lines ranging from $500,000 to $500 million.
Eric has published, edited, and authored numerous books, reports, and major studies on a variety of topics including: advances in biopharmaceutical technology in China, advances in large-scale biopharmaceutical manufacturing, biopharmaceuticals in the US market, cell-culture, media, sera, tissue engineering, stem cells, diagnostic products, blood products, genetics, DNA/PCR purification, and blood components. He also lectures extensively on pricing and channel-management topics and teaches at Johns Hopkins University and American University.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
