H.M. Ribbans, M.B.A., B.S., MT (ASCP), RAC
President
Helen Ribbans is the principal and president of B&H Consulting Services, Inc.  Helen has 38 years of experience in the health sciences industry. Her corporate experience includes Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Technical Services at two of the Johnson & Johnson family of companies.  During her 13 years in industry and more than 20 years as a consultant, Helen has been instrumental in the successful planning, preparation and submission of investigational and marketing applications to US and international regulatory authorities on behalf of companies large and small.  Helen’s depth of knowledge in multiple areas of the health sciences industry is reflected in her ability to gain and retain clients from new start-ups to the global leaders.

Helen has professional credentials in both business and scientific disciplines. She graduated from Fairleigh Dickinson University in Madison, New Jersey with a Bachelor of Science degree in Medical Technology and a Masters in Business Administration. Helen holds certification (RAC) by the Regulatory Affairs Professional Society (RAPS). Helen is an American Society of Clinical Pathologists’ board certified medical technologist.  Her affiliations include membership in the Regulatory Affairs Professional Society, American Association of Pharmaceutical Scientists, Food and Drug Law Institute, Drug Information Association, and American Society of Clinical Pathologists.

Stephanie M. Pierson, B.S., RAC
Vice President

Stephanie, a graduate of Cornell University, was a member of the 1988 and 1992 United States Olympic teams and the 1995 historic all-women’s sailing team that vied for a chance to represent the United States in their defense of the America’s Cup.

Stephanie is a member of The Food and Drug Law Institute and the Regulatory Affairs Professional Society (RAPS); she holds certification (RAC) by RAPS.

 

Elizabeth N. Dupras, B.S., RAC
Senior Project Manager (CMC and RA)
Beth Dupras has 18 years of pharmaceutical industry experience, including specific experience in analytical testing, product stability program coordination and technical writing. She has experience in formulating regulatory strategies as they relate to pharmaceutical analytical development. Beth has an excellent understanding of cGMPs, ICH and FDA guidance as they pertain to US marketing applications. She has demonstrated expertise in preparing, revising, critically evaluating and tracking technical documents, including specifications, methods, method validation protocols and reports, analytical development summary reports and SOPs.

Beth holds a Bachelor of Science degree in Chemistry from Saint Bonaventure University in Saint Bonaventure, New York and holds certification (RAC) by the Regulatory Affairs Professional Society (RAPS).

At B&H, Beth heads up the CMC Team, providing strategy and preparing dossiers for submission to global health authorities.

Bridgette L. Kunst, M.A., RAC
Associate Director, Global Regulatory Affairs 
Bridgette Kunst has 11 years experience in the pharmaceutical industry including Pharmaceutical Development, Drug Discovery, and Process Research and Development. Her areas of expertise are in CMC technical writing and medicinal chemistry. She has demonstrated expertise in providing regulatory CMC guidance and global submission strategy to clients based on FDA, EU and ICH regulations and guidelines.

Bridgette graduated from Widener University in Chester, Pennsylvania with a Bachelor of Science degree in Chemistry. After working as a research chemist at Pfizer and then Bristol-Myers Squibb, Bridgette went to graduate school to further her education. She graduated from The University of Texas at Austin with a Masters Degree in Organic Chemistry.

At B&H, Bridgette provides regulatory strategy and prepares dossiers for submission to global health authorities. Her affiliations include membership in the American Chemical Society and Regulatory Affairs Professional Society (RAPS); she holds certification (RAC) by RAPS.

For the past 15 years, Eileen’s specialty has been in Occupational Medicine and Case Management caring for and directing the medical treatment of complex work-related injuries and illnesses.  In her most recent position before joining B&H, she assumed the responsibility of creating and managing an Occupational Health Center within an existing hospital facility.  Eileen is a member of the American Association of Occupational Health Nurses and the NJ State Association of Occupational Health Nurses.

Eileen is a graduate of St. Mary’s Hospital School of Nursing, Waterbury , CT and holds certifications from the American Board of Occupational Health Nurses as a Certified Occupational Health Nurse Specialist and from the Commission for Case Management as a Certified Case Manager.

Gail L. Walsh, B.S., MT (ASCP)
Project Manager
Gail brings 30 years of Quality Systems and Regulatory Compliance experience in the pharmaceutical, diagnostic and medical device industries.  She has demonstrated technical writing experience for pharmaceutical and diagnostic products.  A member of the Annual Report Team at B&H, Gail is responsible for preparation and submission of NDA, BLA, IND and OD annual reports. Gail also supports B&H clients as a member of the Regulatory Affairs Team.

Rosalind Hafen, M.A.
CMC Project Manager
Rosalind Hafen has 9 years experience in the pharmaceutical industry including CMC Regulatory Submissions and Analytical and Quality Sciences. Her areas of expertise are in CMC technical writing and drug substance raw material specifications.

Rosalind graduated from Colorado State University in Fort Collins, Colorado with a Bachelor of Science degree in Biological Sciences. She went on to the University of Colorado in Boulder , Colorado where she obtained a Masters of Arts in Molecular, Cellular, and Developmental Biology (MCDB). 

At B&H, Rosalind is a member of the CMC team, preparing dossiers for submission to global health authorities. Rosalind is affiliated with Regulatory Affairs Professional Society (RAPS).

Document Management
B&H’s technical staff is supported by a team of experienced document management professionals:  Elaine Rizzo and Maria Roethke. 

Elaine and Maria are experienced in preparation of eCTD compliant documents to meet current FDA submission requirements.  Knowledgeable in the use of various Documentum-based systems and client-specific document templates and word processing software, their professional preparation of documents and submissions ensures all outgoing projects meet the current requirements of both the clients and regulatory health authorities.

Elaine Rizzo
Senior Document Management Coordinator
Elaine has over 20 years of documentation experience in the pharmaceutical industry, supporting the administrative aspect of processing documents for submission to the FDA and global health authorities. 

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