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
Cheminova A/S has worked with B&H since 2005 and the experience
has been positive all the way. The support that we received from
B&H throughout the years has been professional, qualified,
efficient, and friendly. Cheminova A/S would not have been
able to compile high quality dossiers without the help and support
from B&H. I can only give B&H my highest recommendations.
Stine Baltzer Løsmar
Regulatory Affairs Specialist
Cheminova A/S
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
Sol-Gel Technologies Ltd. is a specialty pharmaceutical company
located in Israel. We have worked with B&H for the past 3 yrs as
our Regulatory CRO in the USA. This has been a very positive
experience for Sol-Gel. We have found the B&H staff very
collegial and highly qualified to handle multiple aspects of the
regulatory path in an efficient and skillful manner. They are
very responsive and respectful of their client’s timelines. I
highly recommend B&H.
Stanley Shapiro, Ph.D
Sol-Gel Technologies Ltd.
If I explain my experience with B&H in a few words, it would be
honesty, responsibility, responsiveness, and fully devoted efforts
to accomplish its tasks and to meet client's expectations
regardless of changing situations.
Yong Joon Jo
Kominox
USA, Inc.
B&H has acted as our U.S. Agent for more than two years;
during this time, the collaboration has been excellent, allowing
us to meet the deadlines of our submissions. In addition, B&H has
provided qualified advice and the staff has always been very supportive,
helpful, and friendly.
Isabel Eguidazu, M.D.
Regulatory Affairs
Director
FAES FARMA, S.A.
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
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 the timely preparation of a
specific document, a complete section of a dossier such as Module
3, or can publish an entire dossier for submission in either
electronic or paper media. B&H can also provide an extra staffing
resource for your company. In the latter case, the people they
assign to 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 & Drug Safety
NPS
Pharmaceuticals
Karo Bio is very pleased with the professional regulatory services
provided by B&H. We are getting exactly the type of assistance we
need in a timely manner. The communication with B&H personnel is
excellent and we also appreciate their friendly but yet
professional attitude. B&H has also shown ability to be flexible
and walk an extra mile for their clients when needed.
Elisabeth Augustsson, M.Sc. Pharm.
Director Regulatory Affairs
Karo Bio AB
Spinifex Pharmaceuticals (“Spinifex”) is developing an orally
bioavailable small molecule for the treatment of neuropathic and
inflammatory pain and related disorders. Although we are an
Australian company, all our development activities are being
conducted under an Investigational New Drug application (IND) with the United
States Food and Drug Administration (FDA). Spinifex takes
advantage of the virtual model of drug development where a small
group of in-house employees are augmented by key contractors and
consultants. Utilizing this model, Spinifex assembled an
international project team in 2006 to lead the development of our
current clinical candidate EMA401 and B&H Consulting provides the
regulatory affairs function into this team. The B&H Consulting
team are important members of the EMA401 project team and it has
been a pleasure working with them as we have moved through the
different phases of development. On Spinifex's behalf, B&H
Consulting has been involved in a submission of a large number of
documents to the FDA including our initial preIND meeting request
and information pack, IND submission and ongoing documents related
to our continuing clinical program. As we move deeper into
clinical development, Spinifex will build its in-house team
however B&H Consulting will still be the company's Regulatory
Affairs department as I don't think I can find a better group of
professionals.
Tom McCarthy, Ph.D.
Chief Executive Officer & Managing Director
Spinifex Pharmaceuticals Pty Ltd
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)
We are very pleased with the excellent
services B&H has provided over the past year. The B&H staff is
very professional, collegial and highly qualified to handle
multiple regulatory tasks in an efficient and skillful manner.
They have been very supportive and committed in the process of
preparing and submitting an IND. The regulatory strategic guidance
they have provided has been very valuable. They are very
responsive and respectful of their client’s timelines. I can
highly recommend the B&H team!
Helena Brink Nilsson
Senior
Regulatory Affairs Manager, Clinical Development
Biovitrum
B&H
has done an outstanding job assisting Sopherion Therapeutics Inc.
and LLC in a variety of activities pertaining to the CMC component
of various submissions to FDA.
They have been the key driver in the preparation of an
amended CMC section of an IND and the drafting of modules 2.3 and
3 for the planned NDA submission on Myocet.
B&H has also assisted in the preparation of correspondence to the
FDA and has played a critical role in the development of the
proper strategy to position the Sponsor in dialogue with the
Agency. Based upon
their broad experience and expertise they have guided Sopherion in
the interpretation of and compliance with numerous FDA
regulations. B&H has
always displayed a high degree of professional integrity and
provided unmatched timely availability for each and every deadline
that Sopherion was required to meet.
Salvatore Forenza. Ph.D.
Senior
Exec. V.P. of Regulatory Affairs & Development
James A. Matson, Ph.D.
Senior
Director of Regulatory Affairs & QA
B&H has been a fantastic partner; professional,
supportive and fast. We have always been very satisfied with the
work they have produced for us. It has been extremely
valuable to have such a dedicated partner through this journey!
Eva Arlander
V.P.
Medivir Pharma
Medivir AB
On several occasions working with small biotech companies in
Europe, I have collaborated with B&H Consulting Services, Inc
(B&H). B&H
has been responsible as the companies' Investigational New Drug
(IND) holder, giving regulatory guidance to the companies and also
the filing of regulatory documents to FDA.
Whatever the task, B&H has always worked
accurately, delivered on time
~ and with a smile. Recently, B&H helped us file an electronic-only IND fully organized into
the Common Technical Document (eCTD) format. The process went
smoothly. Needless to say, all further work on this particular
project/compound is greatly facilitated by this approach, as well
as huge volumes of paper saved. I can highly recommend B&H as a
regulatory partner that will get things done.
Karsten
Lundgren,
Ph.D.
Project Director
7TM Pharma
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