A medical device consulting company working with medical device manufacturers around the world

5523 Research Park Drive, Suite 360, Baltimore, MD 410.674.2060

CardioMed Device Consultants, LLC

Affiliate Consultant - Monique Y. Wells, VMD, MS

MEET OUR STAFF

PRESIDENT AND FOUNDER

H. Semih Oktay, PhD

HONORARY VP, ENGINEERING

Daniel J. Chwirut, MS, PE

PRINCIPAL CONSULTANTS

Judith J. Danielson, RN, BSN, MPH

Richard E. Galgon, MD, MS

Elisa D. Harvey, DVM, PhD

Stephen L. Hilbert, PhD, MD

AFFILIATE CONSULTANTS

Candace F. Cederman, MS

Mona M. Advani, BS, MS, MBA

Jodell D. Kause, BS, RAC

Qmed Consulting

Steven R. Koepke, PhD

Pauline E. McEwan, PhD

Wenda C. Carlyle, PhD

Anna Christensen

Monique Y. Wells, VMD, MS

Sherry L. Sparrow, BA

Dr. Wells is an affiliate consultant for CardioMed Device Consultants. She is a veterinary pathologist and toxicologist with 20 years of experience in preclinical safety assessment. Her specialty is toxicologic pathology, which includes primary histopathologic evaluation of animal tissues, peer review of histopathology data, and clinical pathology data interpretation and review. In addition to these services, she prepares and reviews preclinical dossiers, writes expert reports and position papers, and provides due diligence consulting to private industry, governmental and NGO institutions. Her expertise is pertinent to R&D projects involving combination products.

Dr. Wells worked for the chemical, pharmaceutical and cosmetics industries in the U.S. and in France prior to launching a consulting firm, Toxicology/Pathology Services Inc., in 2002. Since that time, she has collaborated with companies developing pharmaceutical and biotech cardiovascular compounds, providing critical review of clinical and anatomic pathology data as well as writing and reviewing preclinical sections of regulatory documents such as IMPDs, INDs, and IBs. An American, she is based in Paris, France. She speaks, reads and writes in fluent French, and has some knowledge of Spanish and German.

Dr. Wells obtained her doctorate in veterinary medicine from the University of Pennsylvania and her master’s degree in veterinary pathobiology from Ohio State University. She is a diplomate of the American College of Veterinary Pathologists, European College of Veterinary Pathologists, and American Board of Toxicology, and is a Eurotox-registered toxicologist. She is currently an Expert member of Pathology Experts, a group of scientists that provides senior level expertise in support of critical, time-sensitive decisions made during the preclinical development of compounds and devices.

CONTACT DR. WELLS

Office: (410) 674-2060

Fax: (410) 674-2133

Email: info@cardiomedllc.com

info@cardiomedllc.com