Robert J. Michalik, Esq., RAC 

Principal Consultant

Professional Experience:

Bob is an attorney and biochemist with over 20 years experience working in the biopharmaceutical and medical device industries.    Through his career, he has held a wide variety of technical, quality and regulatory positions that literally span the scope of new product development and commercialization activities.   

Denise Osborn-Harrison, J.D.

Senior Associate Consultant

Professional Experience:

Denise provides consultative services to hospitals, medical device manufacturers and pharmaceutical companies relating to FDA regulatory compliance generally, and specifically, risk management, post-market surveillance, FDA reporting and quality management system design.

Denise is a former partner in Medical Risk Management Associates, LLC.   Prior to its proprietary software assets being acquired and subsequent dissolution, MRMA, LLC specialized in on-site consultative services to hospital personnel including physicians, compliance officers, risk managers and legal counsel in the following areas:  compliance, business operations, federal and state legislation, medical malpractice, patient safety, process improvement, risk management, disclosure of medical errors, reporting of sentinel events, root cause analysis and failure mode and effects analysis.   Past engagements include collaborations with Healthcare Industry, Harvard School of Risk Management, Columbia Law School, Duke University, The University of Denver Law School, Case Western Law School and The Urban Institute.

Marc P. Pascucci

Associate Consultant

Professional Experience:

Marc brings over 15 years of public and private sector experience to the firm.  Prior to joining RegulatoryPro, he was director of Quality Assurance and Quality Control for Aquafit, Inc., which manufactured post-operative rehabilitation equipment for the physical therapy industry and professional and collegiate athletic teams.  He was also the Principal of Capitol Strategies, a lobbying concern that specialized in mediation between healthcare companies and regulatory agencies.  He has also held director level positions in federal, state and municipal governments.  Marc is a member of the Regulatory Affairs Professional Society (RAPS).

Masters of Science, Regulatory Affairs

for Drugs, Biologics and Medical Devices

Northeastern University

Sigma Epsilon Rho Society Member, awarded in recognition of Academic Excellence

Bette Hecox-Lea, B.S.

Associate Consultant

Professional Experience:

Bette comes to RegulatoryPro from research, where her recent interests focused on cell biology and biochemistry.  She has spent over five years in grant-driven research and over 10 years teaching science as a tutor and laboratory instructor.  Bette is transitioning into regulatory affairs with two years experience in QC/QA for an in vitro diagnostic medical device company.  She is currently pursuing dual MS degrees in Regulatory Affairs and Biology.

Bachelor of Science with Honors

Biological Oceanography / with Chemistry Minor Degree

Florida Institute of Technology, Melborne, FL

Matriculating student

Master of Science, Regulatory Affairs

Northeastern University, Boston MA

Catherine M. Foley, M.S.

Associate Consultant

Professional Experience:

Catherine has worked for over ten years in the “natural foods/dietary supplement” industry for large national retailer, independent retailers and as a manufacturer’s rep for several companies.   Prior to focusing her efforts in this area, she spent two years working for Millipore Corp in the QC lab running several products for quality assurance and standards.   Recently, she has earned her Master of Science degree in Regulatory Affairs from Northeastern University, Boston, MA.

Catherine's strong commitment to helping clients in the dietary supplement industry is evident from her remarks: 

"I have enjoyed working in the dietary supplement industry for over ten years.   I've witnessed tremendous growth and want to remain on the forefront and contribute from a product development and quality/regulatory affairs perspective.  I feel that over the next ten years, this industry will be required to work more closely with the Food and Drug Administration and the Federal Trade Commission in bringing products to market and compliance with new post-marketing regulatory requirements."

Catherine’s academic knowledge of biotechnology practices, her graduate degree in regulatory affairs, and her practical experience in the dietary supplement industry provides prospective clients a unique resource when navigating the shifting regulatory landscape in the nutriceutical industry.

Bachelor of Science, Biotechnology,

Northeastern University,  honors: Magna cum laude

Masters of Science, Regulatory Affairs,

Northeastern University

Nancy O'Neil, RAC

Associate Consultant

Professional Experience:

Nancy brings over 15+ years of business experience in several capacities from the medical industry.    She has considerable experience working in the areas of device manufacturing, original equipment manufacturing (OEM) management, business development and quality and regulatory affairs. 

Nancy is an RAC Certified Professional through the RAPS Association and holds a Bachelor in Science from Syracuse University at Utica College.