Founder, Atlantic505 Consulting
In the complex and highly regulated world of pharmaceuticals, where precision and compliance are non-negotiable, Mr. Scott Groner has carved a name for himself as a trusted expert and transformative leader. With over 30 years of experience shaping best practices in drug development and regulatory affairs, his career stands as a benchmark of excellence, innovation, and dedication.
A Strong Foundation in Science
Mr. Groner began his professional journey with a Bachelor of Science in Chemistry from Western New England College in 1990. He later advanced his studies at Rutgers University, concentrating on Analytical Chemistry, which laid the intellectual foundation for a distinguished career in the pharmaceutical industry.
From Laboratory to Leadership
Starting as a Research Chemist at Exxon Biomedical Sciences in 1992, Mr. Groner quickly demonstrated exceptional skill in areas such as stability testing, method development, and analytical validation. His mastery of instruments like HPLC and GC-MS showcased his technical expertise and attention to detail—qualities that would remain central throughout his career.
Corporate Evolution and Global Exposure
Mr. Groner moved into key Quality Assurance roles at Warner-Lambert and later Pfizer, contributing significantly to GMP compliance across international manufacturing and research facilities. His work supported the preparation of critical regulatory submissions for both branded and generic pharmaceuticals, marking his transition from technical expert to global compliance strategist.
He later expanded his impact by joining a generic pharmaceutical firm, where he oversaw both branded and generic drug development, broadening his scope in regulatory management and lifecycle oversight.
Atlantic505 Consulting: Built on Experience, Driven by Vision
In 2015, Mr. Groner founded Atlantic505 Consulting, a regulatory consulting firm initially based in Somerset, New Jersey, and now headquartered in Tampa Bay, Florida. The firm was born from his commitment to offering specialized, hands-on guidance in a rapidly evolving regulatory environment.
Atlantic505 has become a go-to resource for companies seeking expertise in FDA regulations, including 505(b)(1), 505(b)(2), and 505(j) submissions. Under his leadership, the firm supports clients in product development, manufacturing transitions, and compliance strategies, ensuring their success at every phase of the regulatory process.
Leadership Style and Strategic Impact
As the guiding force behind Atlantic505, Mr. Groner brings a blend of strategic foresight and practical leadership. He emphasizes a strong Quality Systems foundation and cultivates a culture of regulatory excellence among his team. His philosophy focuses not only on staying compliant but on helping clients thrive through proactive, informed decision-making.
Recognition and Mentorship
Mr. Groner’s work has earned him accolades and appearances in respected platforms such as:
- Marquis Who’s Who
- The Wall Street Journal
- Fortune Magazine
- International Association of Top Professionals
Yet, he remains grounded in his role as a mentor, sharing decades of industry insight to nurture the next generation of pharmaceutical professionals. His guidance has helped countless individuals grow in their careers while upholding the highest standards in drug development and compliance.
Ethics, Innovation, and the Road Ahead
Mr. Groner believes that true success lies in continual learning and ethical leadership. His commitment to transparency, integrity, and quality continues to influence not just his clients but the broader pharmaceutical ecosystem. Looking forward, he plans to expand Atlantic505’s global footprint, further solidifying its reputation as a leader in regulatory strategy and consultancy.
Legacy of Excellence
From his early days in the lab to building a respected consultancy, Mr. Scott Groner’s story is one of resilience, innovation, and purpose-driven leadership. His contributions extend far beyond regulatory frameworks—he is helping define what ethical, intelligent pharmaceutical progress looks like in the modern age.
