As an experienced biochemist (B.S., Biochem, 1981), licensed attorney (J.D., 1994) and Regulatory Affairs professional (RAPS RAC certified, 1998) with over 20 years experience in the biopharma and medical device industries, I offer an array of regulatory, clinical, quality and legal services to FDA-regulated client companies. Specialties * U.S. and international regulatory strategy design * "hands on" clinical research and operations support * Regulatory applications drafting and submission services, including FD&C Act Sec. 510(k)s, Investigational exemptions (INDs and IDEs), and marketing approval applications (PMAs, NDAs and BLAs). * Quality System design and implementation per U.S. drug and medical device regulations (21 CFR Part 211, Part 820) and international standards (ISO 13485:2003)
Robert Michalik lives in New York, NY. He has worked for Managing Director and Kinderhook Industries.
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