| Benefits:
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.
Provides peace of mind
Immel Resources LLC is well-respected, with 26 years
of hands-on experience in the pharmaceutical, biotechnology, medical
device and related industries in quality assurance and
compliance.
Quality system experts
We are known as quality system experts. Company
founder Barbara Immel has taught well-respected CAPA and problem
investigation classes since 2000, working with many industry companies
on these systems. She has served as a leader of
grass-roots industry groups in training, documentation, and compliance,
serving
on national training committees for both PhRMA and PDA for eight years.
As the
editor of
the Immel Report and a
member of the
Editorial
Advisory Board for BioPharm magazine,
she talks
frequently with regulatory agency personnel and industry experts. Our
service and advice is always current, thorough, and thoughtful.
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 maintain GXPs.
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 (improving quality systems when under a
consent decree, performing an assessment after a warning letter,
preparing to enter the U.S. or European market, or preparing for a
pre-approval inspection), 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
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.
Free initial consultation
Free initial consultation on all new assignments, and
with prospective clients.
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