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MEET THE TEAM

Concordia Integrated Solutions, LLC is a team of highly respected and experienced experts from the pharmaceutical and consumer healthcare industries. We offer creative and strategic solutions to complex challenges along with tactical execution support.

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FOUNDING MEMBER

David Grob, MS, RAC

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A seasoned Regulatory Affairs leader with over 25 years extensive experience in the consumer healthcare industry. His broad expertise includes OTC monograph policy interpretation

and product support, regulatory strategy for Rx-to-OTC switch projects, OTC monograph / DSHEA labeling and advertising review, claim development, risk assessments, compliance challenges, NAD/FTC issues and resolution, and FDA negotiations and representations at FDA meetings. His contribution to the successful launch of over 450 consumer healthcare products is part of his proud legacy and a demonstration of his ability to navigate complex regulatory landscapes and drive regulatory strategies for novel products while being a strong business enabler. David holds an M.S. in Biology from Adelphi University and a B.S. in Biotechnology from the Rochester Institute of Technology.

“It's not just about navigating regulations—it's about driving business success through informed and creative regulatory strategies.”

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AREAS OF EXPERTISE

CHC Regulatory Affairs

Regulatory Policy Interpretation

Strategy Development

Creative Problem Resolution

Business Acumen

Collaboration

Compliance

Risk Mitigation

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AREAS OF EXPERTISE

Scientific Leadership
Strategic Innovation
Creative Problem Resolution
Business Acumen
FDA Audits
Collaboration
Compliance
Risk Mitigation

FOUNDING MEMBER

Annelies Verbeek, MD

Annelies Verbeek is a highly respected medical executive with broad experience and expertise in medical affairs, clinical development, women’s healthcare, and general medicine.
 
Throughout her career at Sanofi, Boehringer Ingelheim Pharmaceuticals and Organon, she has successfully navigated the pharmaceutical, consumer healthcare, Rx-to-OTC switches, and self-care world. Annelies holds a Doctor of Medicine degree from the University of Utrecht, the Netherlands, and a Diploma in Pharmaceutical Medicine from the Royal College of Physicians, UK.

 “I believe in the power of science, exploration, and storytelling to change the world.”

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FOUNDING MEMBER

Jan Summers, PhD

 

Jan Summers is a highly respected toxicologist with extensive clinical research, strategic management and leadership experience. Her strong scientific expertise was developed by leading preclinical and clinical programs during Phase I pharmaceutical drug development programs, identifying new surgical applications and clinical programs for medical devices, and conducting the toxicology safety assessments for cosmetic products. Her strong interpersonal and business skills ensure

customer focus is maintained, and results are quality driven and

solution oriented. Jan is a postdoctoral fellow in pharmacology

and toxicology at the University of Arizona, Tucson.

Jan holds a Ph.D. in pharmacology and toxicology from

university of Arizona, and an M.S. in medical biology and B.S. in

chemistry and marine chemistry from Long Island University.

"Success in clinical research lies not just in innovation, but in the seamless integration of science, strategy, and collaboration".

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AREAS OF EXPERTISE

Scientific Leadership

Strategic Innovation

Creative Problem Resolution

Cosmetic and OTC Product Safety

Clinical Research

FDA Audits

Compliance Excellence

Risk Mitigation

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AREAS OF EXPERTISE

Corporate Strategy

Innovation

OTC Business/Product/Clinical Development

MEMBER

Donald K. Riker, PhD

Don is recognized for his broad experience and creativity helping science-based consumer businesses use consumer insight and technology to grow revenues and create new opportunities.

He spent 20 years in Personal Healthcare at Procter & Gamble and five years at Chattem Inc. where he became Vice President of Research & Development and Chief Scientific Officer. His responsibilities included product development, quality assurance, regulatory affairs, analytical, safety and consumer affairs.

 

Don is a former Editor-in-Chief, OTC Product and member of the American Academy of Allergy, Asthma & Immunology, American Society of Pharmacology & Experimental Therapeutics, American Society of Clinical Pharmacology & Therapeutics, Infectious Disease Society of America, and The Society for Neuroscience. He has a Ph.D. in Neurobiology from Cornell University, and completed his post-doctoral training in medical research at Yale University.

 “Innovative growth in consumer healthcare lies at the intersection of scientific rigor and consumer insight.”

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MEMBER

Sue James, RAC (US/Global), FRAPS

Sue James is a globally recognized leader in regulatory affairs with a distinguished career in Consumer Healthcare spanning several decades. After earning her B.A. in Chemistry and Biochemistry from the University of York, she began her career with GSK Consumer Health, where she gained hands-on experience in product development before transitioning to regulatory affairs. Sue has held progressively senior roles, culminating in her appointment as Worldwide Head of Regulatory for GSK Consumer Health in 2000.

 

Under her leadership, she built a top-tier regulatory organization, successfully guiding multiple Rx-to-OTC switches, including Tagamet and Voltaren, and overseeing the integration of major acquisitions like Block Drug, Novartis Consumer, and Pfizer Consumer Health. An active participant in key industry associations, Sue has also served on the Board of the Regulatory Affairs Professional Society.

 

After leaving Haleon in 2024, she continues to champion opportunities that empower self-care with trusted, high-quality products, now also as part of the Concordia Consortium.

“My mission is to navigate global regulations with rigor, transforming challenges into opportunities that empower consumers and elevate the industry.”

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AREAS OF EXPERTISE

Global Regulatory Affairs

Rx-to-OTC Switching

Compliance

Strategic Integration

Collaboration

Advocacy

Organizational Development

Creative Problem Solving

Risk Identification

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