MANNHEIM, Germany, Sept. 9, 2014 /PRNewswire-iReach/ -- September 9, 2014 - PharmaLex GmbH (www.pharmalex.com) has announced today that Andrew S. Verderame, MBA, RAC, has joined the company as Senior Advisor. He will establish the PharmaLex U.S. affiliate company and lead business development in the U.S. Mr. Verderame brings a wealth of experience to PharmaLex, including leading over one hundred meetings with FDA, managing multi-site regulatory teams for both large and small pharmaceutical companies, and presenting to FDA Advisory Committees, with successful outcomes. He previously held senior regulatory affairs positions at EMD Serono, Replidyne, and Bayer HealthCare. Mr. Verderame and his U.S. based expert staff will provide FDA-specific guidance and consulting services for clients seeking drug development and product life cycle maintenance activities in the U.S.
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"We are very pleased that Andrew has joined PharmaLex," stated Dr. Tilo Netzer, Chief Operating Officer. "His vast experience in FDA interactions, new product approvals, and relationship building will greatly aid our clients looking to develop new medicinal products in the U.S., the world's largest pharmaceutical market."
ABOUT PHARMALEX : PharmaLex is an internationally recognized consulting firm and service provider for the pharmaceutical industry, headquartered in Mannheim, Germany. We are focused on providing a complete range of services and expertise covering product development, regulatory affairs, pharmacovigilance and lifecycle management. Quality, reliability, efficiency, flexibility and forward-looking strategic planning are the foundations of our success in working with pharmaceutical companies worldwide.
PharmaLex supports clients with integrated US and EU regulatory strategies as part of their global development projects. PharmaLex can now deliver a full spectrum of US regulatory services such as FDA meeting preparation and conduct, regulatory strategy, CMC consulting, FDA promotional and labeling support, electronic submissions and project management. In addition, PharmaLex also provides services as US agent for clients without their own regulatory function in the U.S.
Media Contact:Andrew S. Verderame, Pharmalex GmbH, 203-415-7721, andrew.verderame@pharmalex.com
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SOURCE Pharmalex GmbH
