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Consulting Services |
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McArdle & Associates
provides CMC consulting service to the pharmaceutical industry for
both small molecules and oligonucleotides. Jim can work with clients
either on a project basis or an hourly basis. Jim's areas of particular
expertise include the following: |
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CMC development
strategy |
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The goal of CMC development
is to enable reliable, cost-effective production of commercial drug
product that is safe and efficacious over its entire shelf life. The
effort to accomplish that goal begins in the early days of the development
program.
Further
information > |
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Worldwide CMC
regulatory strategy |
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Jim's twelve years of
experience working on ICH Expert Working Groups makes him extremely
well qualified to provide CMC regulatory strategy that will serve
multinational requirements. His experience living and working in the
United Kingdom and leading a two-year project in Asia add to his international
credentials. |
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cGMP and 21st
Century Quality Systems |
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The pace of innovation
in modern quality systems in the pharmaceutical industry has never
been more rapid. Recent events have led to renewed energy in examining
all aspects of production of supplies for clinical or commercial use.
Jim will help keep your programs in line with current thought. Further
information > |
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Oligonucleotide
synthesis and scale up
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Oligonucleotides are
being developed for both therapeutic and diagnostic purposes. Synthesis,
analysis, stability, and formulation of oligonucleotides all require
many special considerations. Jim’s experience of working with
this class of molecule for nine years will help to ensure success
of your development effort |
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Analytical development
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A strong analytical
development program will assist all aspects of pharmaceutical development,
including process improvement, synthesis scale-up, formulation development,
and stability studies. Perceived deficiencies in analytical technology
remain a leading cause of delay in approval of marketing applications.
Jim has particular strength in this area to help you build a strong
analytical program.
Further information > |
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Due diligence,
outsourcing, and management of contract manufacturers |
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Jim can evaluate contractors
or potential partners in terms of both technical competence and quality.
He can also manage the execution of assigned projects. |
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Stability study
design and data interpretation |
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Developing a fundamental understanding
of processes of degradation is critical to the success of development
of both drug substance and drug product. Jim can help design mechanistic
studies as well as the formal stability studies necessary to support
regulatory submissions. Further information > |
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Preparation of
applications for clinical trial or marketing authorization |
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Jim was deputy topic
leader representing PhRMA in development of the ICH guideline “The
Common Technical Document for the Registration of Pharmaceuticals
for Human Use: Quality.” He has the understanding of the organization
and underlying philosophy of the guideline that comes from having
participated in creating it.
Further information > |
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Out-of-specification investigations
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Jim can help implement
strategies to minimize out-of-specification (OOS) results. However,
if OOS results do arise, it is important to investigate them thoroughly
to understand the underlying cause, to put into place corrective actions,
and to meet regulatory expectations. Further information > |
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