| Benefits:
Avoids compliance problems with the U.S. Food
and Drug Administration and World Regulatory Agencies
Immel Resources LLC is
well-respected, with 28 years
of hands-on experience in the pharmaceutical, biotechnology, medical
device and related industries in quality assurance,
regulatory compliance, and
training. We are considered quality systems
experts. Company founder Barbara Immel
has served as chairperson of the Annual FDA Inspections
Summit hosted
by FDAnews since the conference's inception. She is also chair of the
quality track subcommittee for MedCon 2010, a new medical device
conference
being
cosponsored by the U.S. Food and Drug Administration and by the
nonprofit Xavier University. As a conference organizer, and as a former
long-term compliance columnist for
BioPharm magazine, our company founder talks
frequently with
regulatory agency personnel and industry experts. Our advice is always
current, thorough, and thoughtful.
Saves you time, and reduces your workload
If you have been assigned a project that you do not
have time to do, we can help. After an initial consultation, we
get to
work immediately to help solve a challenge, improve a system or provide
training.
Quality system experts
Company
founder Barbara Immel has served as a leader of
grass-roots industry groups in training, documentation, and compliance,
serving
on the national training committees for both PhRMA and PDA for eight
years. She is the author of the Quality Assurance of Pharmaceuticals
chapter for the Dekker Encyclopedia
of
Pharmaceutical Technology. She has published more than 50
articles on quality and compliance topics over the past 20 years in the
trade journals Pharmaceutical
Technology, Medical Device & Diagnostic Industry, BioProcess
International, and BioPharm.
She has been teaching well-respected compliance
classes
for more than 20 years, specializing in CAPA and investigations courses
since
2000.
Speeds products to market and reduces risk
By helping companies and organizations to be in
compliance, we help organizations successfully pass major regulatory
inspections and introduce innovative new products to market.
Creative, innovative solutions, and international experience
We are known for our ability to see to the heart of
an
issue, and to suggest creative yet practical, long-term
solutions. We have successfully worked with industry employees in more
than 18
countries
throughout North and South America, Europe, Asia, and the
Caribbean.
Practical information that you can
immediately
use
We offer practical suggestions on how to establish or
improve a quality system -- not simply identify any deficiencies. For
high-profile assignments, such as preparing for an FDA pre-approval
inspection, improving quality systems when under consent decree,
helping an organization recover from an FDA warning
letter, or preparing to enter the U.S. market, we work with a network
of experienced and
well-respected professionals. The final decision on any proposed
team member(s) is up to you.
Reduces cost, and free initial consultation
You pay only for the services or project that you
need. A written estimate is always provided, and any changes are
discussed and mutually agreed upon in advance. We always provide a free
initial consultation on all new assignments, and
with prospective clients.
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