H.M. Ribbans, M.B.A., B.S., MT(ASCP)
Helen Ribbans is the principal and president of B&H Consulting Services, Inc.  Helen has more than 31 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 her 18 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 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.

Marguerite is Project Director of the Annual Report Team, coordinating the activities for the timely submission of annual reports for more than 100 Investigational New Drug (IND) and New Drug Applications (NDA) each year.

Kathy was recipient of several Professional Achievement Awards.  Kathy graduated with a Bachelor of Science degree in Medical Technology from Fairleigh Dickinson University in Madison, New Jersey and is a member of the American Society of Clinical Pathologists. 

As a member of the Annual Report Team at B&H, she is responsible for the preparation and submission of NDA Annual Reports.  Kathy also supports B&H’s clients as a member of the Regulatory Affairs Team.

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.

Elizabeth N. Dupras, B.S.
Beth Dupras has 15 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.

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

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 requirements of both the clients and regulatory health authorities.

Actelion Clinical Research, Inc.
Action Pharma A/S
Astion Pharma A/S
Boston Life Sciences, Inc.
Bristol-Myers Squibb 
Bristol-Myers Products
Colgate-Palmolive Company
CURA Pharmaceutical Company, Inc.
EBEWE Pharma Ges.m.b.H. Nfg.KG
Egalet A/S
Enzon Pharmaceuticals, Inc.
Fugisawa USA, Inc.
Genmab A/S
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INO Therapeutics
Johnson & Johnson Consumer & Personal Products Worldwide
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Maganin Pharmaceuticals, Inc.
Novartis Consumer Health, Inc.
Novo Nordisk Pharmaceuticals, Inc.
Praecis Pharmaceuticals, Inc.
Roche Pharmaceuticals, Inc.
Schering Plough Animal Health
Synthelabo Recherche
Takeda America, Inc.
Zenith Goldline Pharmaceuticals
Zealand Pharmaceutical A/S
Zymenex A/S

Testimonials
We are very happy with the services B&H has provided over the past two years.  They have worked collaboratively with EBEWE to successfully submit several ANDAs.  B&H has been an integral part of responding to the chemistry, microbiology and labeling deficiencies from FDA for these ANDAs.  B&H has also successfully prepared and submitted a 505(b)(2) NDA for EBEWE, which recently received FDA approval for the US market.  They have undoubtedly contributed to EBEWE's successful entry into the US market.  I would highly recommend the B&H team!
Dr. Wolfgang Schmitzberger
Chief Operations Officer
EBEWE Pharma Ges.m.b.H. Nfg.KG
October 2007

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The co-operation with B&H Consulting was excellent due to their professional and committed work. What impressed me the most was how fast and yet still accurate things were handled. All requests were dealt with promptly and to our satisfaction.
Dr. Christian Liek
Head of Regulatory Affairs
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October 2007

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Hallmarks of dossier services by B&H Consulting:  timely, professional, experienced, thorough, and, most important of all, in step with latest developments on regulatory dossier requirements.
HY Guh, Ph.D.
Chairman
Andaxa LLC
 
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We at Cura are very pleased with the value B&H provides us for our Regulatory requirements. We have found them to be very thorough and comprehensive in their approach to providing solutions for our issues. They are a very knowledgeable group with a "human" touch.  
Fabio Lanzieri
President
Cura Pharmaceutical Company, Inc.  
 
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Genmab is a Scandinavian based (Denmark) company, developing fully human antibodies for therapeutic use. Genmab was founded in year 1999. Genmab had our first IND filing with the FDA in year 2000, with B&H Consulting Services acting as our US agent and liaison to the FDA. Our collaboration has been so successful, that we have decided to slow down activities towards filling regulatory affairs positions in our US affiliate. Still today, B&H is our liaison to the U.S. FDA. Their dedication toward delivering quality work on time, along with clever consultancy, has made them a very important extension to Genmab that we would rather not be without. I can only recommend B&H Consulting Services to any company who needs regulatory services.  
Hanne Damgaard Jensen
Director of Regulatory Affairs, QA & Project Management
Genmab A/S
 
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In my experience over a number of years, B&H Consulting Services, Inc. has demonstrated the ability to service both “big pharma and little pharma” with a variety of regulatory services.  They can complete a discrete job such as preparing a specific document for submission, or can provide an extra staffing resource within your company.  In the latter case, the people they place within your company achieve a level of transparency based on professionalism, competencies, and an innate ability to feel and respond to the pulse of the organization.  B&H can also provide strong regulatory strategic guidance based upon a wealth of regulatory experience and intelligence and expertise in knowing the current regulations.
S. Cottrell, Ph.D.
Vice President Regulatory Affairs
Novo Nordisk A/S
 
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During the several years that B&H Consulting Services prepared scientific documents, INDs, NDAs and amendments for projects with which I was associated, one could not have asked for more from a consulting company in the area of CM&C document preparation.   The quality of the work, the responsiveness to changing needs, the adherence to milestones and deadlines were superb and contributed immensely to the successful registration of a number of products in an expeditious manner.  B&H is a unique consulting company to the pharmaceutical industry which provides valuable services to clients.
Irwin S. Gibbs, Ph.D.
Director of Pharmaceutical Development
(Retired)
 
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What impresses me about B&H is that, to them, a deadline is a deadline, not a suggestion. Not only did they meet my deadlines with top-notch work, they were professional, responsive, courteous, and adaptive. It was a pleasure working with them.
Yinka Williams, Ph.D.
Director, Chemical and Pharmaceutical Development Team Leader
 
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B&H Consulting Services, Inc. was recommended to us by our Danish business contact. We have worked with B&H on a number of projects since early 2002.  They have proven to be an invaluable contact within the US for our projects.  Their staff has a great level of expertise in a number of different areas, including CMC and clinical research.  Their good contacts within the FDA have greatly facilitated the progress of development projects to the IND stage. In our experience with B&H, all project issues are dealt with promptly and with a great attention to detail.
Jürgen Regenold  
Chariman
Dr. Regenold GmbH
 
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Sample Projects

Since 1988, B&H Consulting Services, Inc. has supported many clients with diverse needs.  Prior to beginning a project, we assess the company’s needs and requirements to gain an understanding of how B&H can best help accomplish the task at hand.  As a service company, we are committed to understanding and meeting each client’s needs on an individual basis.

• Successfully managed the coordination, technical writing and compilation of Chemistry, Manufacturing and Controls (CMC) documentation for both human and veterinary applications submitted to United States, Canadian and European Health Authorities, ensuring that all information was accurate and complete, meeting currently acceptable standards, (i.e., ICH, 21 CFR, etc.)
• Worked with CMC teams to compile amendments, supplements and variations to global regulatory submissions
• Contracted and monitored analytical methods development studies on behalf of client companies 
• Addressed Chemistry, Manufacturing and Controls (CMC) queries from Health Authorities around the world; drafted responses and forwarded to CMC team for review and approval; worked with company affiliates to successfully submit timely responses to queries, resulting in marketing approvals

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• Established policies and procedures followed for the submission of over 110 IND and NDA Annual Reports each year.  For each annual report, activities included:
• issuance of the “Call for Information”
• collection, review and verification of source data for accuracy
• preparation and circulation of a draft report for comments and approval
• revisions to the annual report, as necessary
• preparation of the appropriate FDA form and cover letter
• issuance of the final annual report, FDA form and cover letter for final review and signature for FDA submission and internal distribution

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• Coordinated and filed numerous initial Investigational New Drug (IND) applications
• Provided guidance to the sponsors on the content and format of the initial applications
• Reviewed source documents to ensure all items of the IND were accurate and complete, meeting requirements of 21CFR 312.23
• Prepared and collated documents to meet FDA’s requirements, as well as B&H standards and the client internal requirements
• Volumized, paginated, and created overall Table of Contents for the INDs, and prepared the cover memo and FDA Form 1571 for inclusion in the submission  

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• Working on-site at client locations, reviewed and compiled documentation for submissions, prepared cover letters and corresponding required FDA forms; coordinated all activities related to photocopying, pagination and submission.
• Represented non-US companies as United States Agent to FDA
• Compiled and filed information and protocol amendments, safety reports, annual reports and general correspondence to ensure compliance with all FDA regulations
• Acted as liaison with FDA on behalf of client and provided regulatory strategies for sponsor identified issues and questions
• Assisted with drafting Core Data sheets, USPI and SmPCs
• Assisted clients through the Mutual Recognition Procedure (MRP)
• Requested meetings with FDA; prepared “Briefing Packages” submitted to FDA in advance of meetings

• Submitted applications for assignment of a Labeler Code for a new private label distributor
• Prepared the necessary forms for registration of Drug Establishment (Form FDA 2656) and Drug Product Listings (Form FDA 2657)
• Interacted with FDA to ensure submission of accurate documentation
• Completed and filed documentation for state registrations, ensuring successful distribution of product

United States Agent

• Successfully represented international companies at meetings with FDA
• Coordinated activities and prepared background document submissions, i.e., “briefing packages” with questions for FDA consideration in advance of regulatory meetings
• Prepared, reviewed documentation and submitted initial IND Applications
• Prepared, reviewed and submitted subsequent amendments (CMC, clinical, pharmaco-toxicological), general correspondence, responses to requests for information, safety reports
• Prepared and coordinated meetings (pre-IND, end of phase 2, pre-NDA) between sponsor and FDA
• Assisted sponsors in regulatory strategy development and implementation
• Successfully filed Orphan Drug applications
• Submitted requests to FDA for fast track review
• Assisted in FDA negotiations on preclinical and clinical study requirements
• Compiled, reviewed and submitted drug master files and subsequent updates, as required
• Compile, review and submitted original New Drug Applications
• Coordinate activities to gain FDA approval of marketing applications

Quality Control/Assurance

• Conducted GMP audits of contract manufacturing facilities in the US and abroad
• Established issuance/control system for Standard Operating Procedures (SOPs)
• Prepared quality-related SOPs and associated forms for a start up company
• Set up quality control program for release of drug product, including attributes inspection and testing  
• Conducted GMP training for quality and warehouse personnel

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