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Nach is an experienced pharmaceutical and medical device industry professional of 22 years. He received his B.S. in Pharmacy from the University of Sciences- Philadelphia and a Masters in Regulatory Science from Long Island University-Brooklyn. He has worked in senior positions across clinical operations and regulatory affairs for drug and device companies. In addition to industry appointments, he was previously an adjunct professor in the Drug Regulatory Program at Long Island University and a visiting professor at University of Southern California.
His industry experience is comprised of consultations on clinical trials, presenting at FDA and EMEA meetings along with speaking engagements at international industry conferences. Nach has personally led the efforts in the past on a variety of regulatory submissions. He also led a previous medical device start-up and experienced in growth strategies of small to mid-sized healthcare companies. Currently Nach is Vice President of Development Strategy at Premier Research – a Clinical Research Organization focused on the biotechnology industry. He is an advisor to our firm and is based in Irvine, California.
Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.
We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.
International Regulatory Advisor - Medical Device Consulting - FDA Dossier Submissions - Complex FDA Regulatory Due Diligence - Orange County FDA Regulatory Risk Analysis - Irvine Quality Compliance Advisor - Drug Approvals - Medical Device clearances