Profile

Christopher Smith

President

Contact Details

President
7950 Old River Rd
Burgaw, NC
United States
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Bio

Christopher Smith is the Founder and President of Coastal Pharmaceutical Consultants, Inc. Chris has more than 35 years of experience having held senior positions at the FDA, large and small pharmaceutical companies and contract research organizations.

Chris began his career in 1976 as an FDA Investigator and, over the course of 12 years, moved into positions of increasing responsibility in the Agency including Assistant Director of Congressional Operations, Associate Director of Program Management and Deputy Associate Commissioner for Public Affairs. A graduate of FDA’s Mid-Level Executive Development Program, he was one of the key authors of the Agency’s last major rewrite of the IND and NDA regulations and managed several key FDA regulatory initiatives including establishment of tamper-resistant packaging regulations following the cyanide poisonings with Tylenol in 1982.

In 1987, Chris joined Abbott Laboratories as Associate Director of Regulatory Affairs. At Abbott he was responsible for managing regulatory affairs activities including INDs, NDAs and BLAs in the neuroscience and cardiovascular therapeutic areas. In 1992, Chris moved to the CMO business as Director of Regulatory Affairs at Applied Analytical Industries soon becoming Sr. VP of Global RA and QA and a member of the Executive Committee as the company went public as AAI Inc. and expanded with the addition of clinical (CRO) services in the US, Europe, Japan and China. In 2001, Chris took the opportunity to join a small group of entrepreneurs to establish Endeavor Pharmaceuticals, a start-up focused on women’s health. Endeavor was acquired in 2004 and Chris returned to AAI to assist in its restructuring and rebranding to AAIPharma, the sale of the clinical business, and a return to the company’s roots as a CMO. In 2011, Chris established Coastal Pharmaceutical Consultants offering independent regulatory affairs and quality assurance services to the pharmaceutical industry.

Coastal Pharmaceutical Consultants conducts quality assurance audits and has assisted many firms in the preparation for successful FDA audits in the US, Europe, India, Japan and the Middle East. Chris has helped clients respond appropriately to FDA 483s and Warning Letters and implement remediation plans where FDA has found regulatory compliance problems. Coastal Pharmaceutical Consultants also offers regulatory affairs assistance including the conduct of due diligence, the development of regulatory strategies and FDA meeting packages, and assistance with regulatory filings. Chris has also served as an expert witness with respect to GMPs, drug development, ANDAs and FDA regulations. He is the named US Agent and regulatory representative on FDA filings for several clients.

Chris has a Bachelor's degree in Biology from Michigan State / Oakland University, Rochester, MI, and a Master's degree in Microbiology from Wayne State University, Detroit, MI. He is a member of the Drug Information Association, the Regulatory Affairs Professional Society (certified RAC), the Parenteral Drug Association, the American Society for Quality (certified CQE) and is a board member of RegAffairsNC. He has several publications including "Laboratory Operations: A Vital Link," GMP Compliance, Productivity, and Quality (Interpharm Press, 1998), “Speed Dating: the Rapid Way to Phase I Clinical Studies,” PMPS Journal (Winter 2006) and “A Fish Story: The One That Got Bigger,” Communicating in a Healthcare Crisis, (FDANews, 2007). He is a sought-after speaker and panel participant on regulatory and quality issues affecting the pharmaceutical industry and has presented on topics including drug development, GMPs in the development setting, 505(b)(2) NDAs, Quality Systems, quality agreements, regulatory compliance, outsourcing and vendor management, stability, PAIs, and interactions with regulatory agencies.