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
hameln rds gmbh
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.
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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