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To
summarize my services that can be
provided, I am an international
regulatory consultant with global
expertise in pharmaceuticals – Rx and
OTC, drug products and active
pharmaceutical ingredients (APIs) –
nutritional supplements and medical
devices and diagnostic products.
I have
extensive experience in the areas of
pharmaceutical manufacturing operations,
quality systems and risk management,
compliance and regulatory affairs - for
APIs and dosage forms. I am very well
versed in conducting domestic and
foreign plant audits for CGMP compliance
and integrity, supply chain management
and control and also quality systems
evaluation, as well as in preparing and
filing for approval of Drug Master Files
and dosage form product registrations in
hard copy or electronic format (eCTD).
Along with these activities, I am
experienced in preparing for and
satisfying U.S. FDA regulatory
inspections for facilities and
documentation. I am especially
experienced in working with people and
training them in these activities. My
global expertise has been accomplished
in companies that I have worked for and
with - and in serving on various
committees with regulatory agencies,
including the U.S. FDA. Further, I am
experienced in working intensively with
foreign companies to register products
in the U.S. - such as companies from
China, India, Europe and Mexico. Other
services that I provide include due
diligence and expert witness activities.
In my past experience, I worked for an
Indian pharmaceutical manufacturer (of
Active Pharmaceutical Ingredients and
Drug Products), with corporate
headquarters in Mumbai, for five years.
I was their U.S. based person to train
people to develop Drug Master Files and
ANDAs toward product registrations,
instruct people in preparation for
successful regulatory inspections
including the U.S. FDA and create and
implement programs to upgrade the
factory and quality systems. Also, I
functioned to establish joint ventures
for marketing partners. In this manner,
we established superior credibility with
the U.S. FDA and obtained numerous
product registrations without obstacles
and, in some cases, with inspection
waivers. Also, I established a personal
relationship with the Indian regulators.
Some recent formal speaking engagements
include being a speaker and moderator at
an IPA/PDA seminar in Mumbai, India in
January 1998, on validation. Also, I
presented at the annual meeting of the
Indian Pharmaceutical Association in
January 2000 in Hyderabad, India, on
validation. In March 2003, I spoke in
Hangzhou, China, on preparation of DMFs.
In 2004, I presented two day training
seminars on the U.S. FDA CGMP
regulations and guidances to 160 people
of the Chinese sFDA and API and dosage
form manufacturers in Worli, China in
April and an additional training session
to more than 150 people of the Chinese
sFDA and pharmaceutical manufacturers in
Beijing in September. In September 2009,
I presented two-two days’ training to
people of the Chinese sFDA on U.S. and
EU plant inspection requirements and
procedures and trends in CGMP
requirements and regulations - one
session in Yantai, China and the other
session in Changzhou. I was a moderator
in a PQRI-FDA workshop session in
December 2010 in Bethesda, Maryland, on
process drift in the manufacture of
APIs. Also, I have worked for one year
with an API manufacturer in Tianjin,
China and helped them to pass a U.S. FDA
inspection very favorably, after they
received four Warning Letters from the
U.S. FDA following four unsuccessful
inspections over a six year period. |
