Service: Pharmaceutical Consulting
Company: Atlantic505 Consulting
Location: Land O Lakes, Florida, United States
W. Scott Groner, a pharmaceutical consulting and founder of Atlantic505 Consulting, has been recognized by Marquis Who’s Who Top Healthcare Professionals for dedication, achievements, and leadership in pharmaceutical regulatory affairs and quality assurance.
With more than 30 years of experience to his credit, Mr. Groner has excelled as pharmaceutical consulting services at Atlantic505 Consulting since 2015. In this capacity, he educates and guides his clients through meetings, assesses regulatory and compliance needs, and offers various consultation, development, and review services, including those for 505(b) or 505(j) submissions, and good manufacturing practice audits. In addition, he has provided significant amount of time in supplement submissions, SOP development, and provided independent PQA (product quality assessment) or CEP (compliance enhancement plan) to FDA district office. For the past 4 years, Mr. Groner has primarily been supporting oncology NDA submission activities and compliance advice.
Mr. Groner began his career as a research chemist at Exxon Corporate Research from 1990 to 1995. He found success at Warner-Lambert, now Pfizer Inc., as quality assurance specialist from 1996 to 2001. Later as an associate director of regulatory affairs and quality assurance at Kali Laboratories Inc.
Mr. Groner continued his career at Duramed Pharmaceuticals as associate director of regulatory compliance from 2001 to 2002. He established himself as head of regulatory affairs and compliance at KVD Pharma Inc. His final contribution as an employee was at Tris Pharma, Inc. as head of regulatory affairs and compliance from 2006 to 2015.
Before embarking on his professional path, Mr. Groner pursued an education at Rutgers Preparatory School where he obtained a diploma in 1983. He continued his academic efforts at Western New England College, earning a Bachelor of Science in chemistry in 1990. Subsequently, he expanded upon his professional knowledge studying for a master’s degree in analytical chemistry at Rutgers State University.
Mr. Groner is proud of taking on leadership roles as a consultant who helped build several startup companies, including his own consultation business. His roles have allowed him to use and develop his expertise in regulatory affairs and quality assurance. He enjoys the experience because he voices his professional opinions and defends them. In addition, he has always found it fulfilling to mentor others and ensure they perform accurately. He provides pro bono professional guidance and advice to his past associates.
Mr. Groner chose to be a leader and mentor rather than a follower. He taught himself to develop his skills and succeed, remaining adaptable to frequent changes in government regulations. In the immediate future, he intends to maintain his successful business before retiring perhaps in five years.
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