Our Team

Nigel Smart – Founder

Nigel Smart – Founder

Although most consulting groups in the Life Sciences & Healthcare sectors still consist of awkward one-size-fits-all approaches, Smart Pharma Consulting is a progressive consultancy committed to going the extra mile to provide specific technical and regulatory compliance services to our clients.  Your operation is unique, and the solutions that will bring you the best value and results must be equally unique.

While the demands of our modern Pharmaceutical, Biotechnology, Vaccine, Biologics and Medical Devices industries are better served by the focused consulting approach where no single fixed team can have all the skill sets necessary to meet every client’s needs in today’s fast-changing economic and compliance landscape.

Smart Pharma Consulting’s internal core team is led by founder, Nigel Smart, who has over 30 years of industry-specific experience with such companies as SmithKline Beecham, Sterling Winthrop, Allelix Biopharmaceuticals and consulting with the FDA.  Combined with our other team members, who average 15-20 years of industry experience each, you have access to highly talented consultants who can provide you with solutions that are timely, focused and immediately applicable for you.

Smart Pharma Consulting prides itself on our dedicated team of consultants that bring extensive, high level expertise to the company. Nigel can lean on his team of hundreds of consultants when it comes to any given client project. He’s taken extraordinary steps to supplement the industry experience of her internal core team by investing over 20 years in developing an extensive and proprietary network of dozens of key industry and compliance experts.  Because of these deep relationships, Smart Pharmaceutical Consulting. can bring in as many — or as few — precisely-selected consultants as needed on almost any project, for any sized company based on the unique needs of your actual operation.

At Smart Pharma Consulting, we make it our goal to provide outstanding lean manufacturing services to our entire client base. By doing this, we aim to provide nothing less than premier technical advice to our clients, who truly lean on our expert analysis and remediation practices. Let our team rev up your company’s performance and compliance in no time. Contact us today for a free consultation.

He joined the original AAIPharma in 1992 following five years as Associate Director of Regulatory Affairs in Abbott Laboratories’ Pharmaceutical Products Division. Mr. Smith began his regulatory career as an Investigator in the Detroit District of the U.S. Food and Drug Administration and spent 12 years with FDA in positions of increasing responsibility including Assistant Director of Congressional Operations, Associate Director of Program Management and Deputy Associate Commissioner for Public Affairs in Rockville, MD. He was one of the key authors of FDA’s last major rewrite of the IND and NDA regulations in the 1980s and managed several other key FDA regulatory initiatives such as the tamper-resistant packaging regulations following the cyanide poisonings with Tylenol in 1982. Mr. Smith has a Bachelor’s degree 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 and the American Society for Quality (certified CQE). 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, 505(b)(2) NDAs, GxPs, compliance, outsourcing, stability, PAIs, interactions with regulatory agencies and controlled substances.