In the intricate world of pharmaceuticals, where regulatory compliance and quality assurance are paramount, Mr. Groner stands as a beacon of expertise and leadership. With over three decades dedicated to shaping and guiding the industry, Mr. Groner's journey is one of continuous achievement and profound impact.
In
the intricate world of pharmaceuticals, where regulatory compliance and quality
assurance are paramount, Mr. Groner stands as a beacon of expertise and
leadership. With over three decades dedicated to shaping and guiding the
industry, Mr. Groner's journey is one of continuous achievement and profound
impact.
Early Career Foundations
Mr.
Groner's career trajectory began with a solid educational foundation, earning a
Bachelor of Science in Chemistry from Western New England College in 1990. He
further honed his expertise through graduate studies at Rutgers, The State
University of New Jersey, focusing on Analytical Chemistry. This rigorous
academic background laid the groundwork for his subsequent roles in the
pharmaceutical sector.
From Research to Regulatory Affairs
Entering
the industry as a Research Chemist at Exxon BioMedical Sciences in 1992, Mr.
Groner's analytical prowess and commitment to excellence quickly became
evident. His roles spanned critical areas such as stability testing, method
development, and validation, crucial to supporting toxicology and preclinical
studies. His proficiency with an array of analytical instruments, from HPLC to
GC-MS, underscored his technical acumen and attention to detail.
Navigating Corporate Landscapes
Transitioning
to Warner-Lambert and subsequently Pfizer, Mr. Groner assumed pivotal roles in
Quality Assurance within their Product Development and Pharmaceutical Science
divisions. His responsibilities extended globally, overseeing GMP compliance
across diverse facilities and supporting the submission of regulatory
applications essential for product approvals.
In addition, moved to a generic drug company and later combined roles of
brand/generic drug development.
Founding Atlantic505 Consulting: A Vision Realized
In
2015, driven by a desire to offer specialized expertise and proactive regulatory
guidance, Mr. Groner founded Atlantic505 Consulting in Somerset, New Jersey and
currently settled in Tampa Bay, Florida. The firm quickly established itself as
a trusted advisor to pharmaceutical companies navigating complex regulatory
landscapes. Atlantic505's service portfolio includes comprehensive consultation
on FDA regulations, specializing in 505(b)(1), 505(b)(2), and 505(j)
submissions. Mr. Groner's leadership ensures meticulous oversight in product
development, manufacturing changes, and product life-cycle management.
Leadership and Strategic Vision
At
the helm of Atlantic505, Mr. Groner blends strategic vision with hands-on
leadership. His approach is characterized by a meticulous planning ethos,
empowering personnel with in-depth FDA regulatory knowledge. This methodical
guidance extends beyond routine compliance, emphasizing the development and
implementation of robust Quality Systems crucial for seamless R&D to
production transitions.
Industry Recognition and Commitment to Mentorship
Mr.
Groner's contributions have not gone unnoticed. He has been recognized in
prestigious forums such as the Marquis Who’sWho,Wall Street Journal, Fortune
Magazine, and the International Association of Top Professionals;, affirming
his stature as a distinguished leader in pharmaceutical consulting. His
commitment to mentorship underscores his dedication to the industry's future,
sharing insights gained over decades of navigating evolving regulatory
frameworks.
Personal Philosophy and Future Outlook
Beyond
professional accolades, Mr. Groner's success is rooted in a personal philosophy
of continuous learning and adaptation. He remains steadfast in his pursuit of
excellence, advocating for ethical practices and stringent quality standards
within the pharmaceutical sector. Looking ahead, Mr. Groner envisions further
expansion for Atlantic505 Consulting, reinforcing its position as a cornerstone
of regulatory expertise and client trust.
Mr.
Groner's journey through the pharmaceutical industry is a testament to
perseverance, expertise, and leadership. From his early days as a Research
Chemist to founding Atlantic505 Consulting, he has exemplified the highest
standards of professionalism and dedication. His impact resonates not only
through his consultancy but also through the countless professionals he has
mentored and inspired. As the industry continues to evolve, Mr. Groner remains
a guiding force, ensuring compliance, quality, and innovation in pharmaceutical
practices worldwide.
