| ATTENTION ! YOUNG COMPANIES |
While we are interested in working with U.S.
companies with interests in China, most of our work
has come from companies in Asia (mainly China) who
wish to sell their products in the U.S. For that reason
we have concentrated on foreign companies, but we
would like to work with U.S. based companies as well.
We feel that we can offer valuable services and
insights to companies who wish to go to Asia to sell or
outsource products and intermediates.
We will work with companies located in Asia to prepare
them and their facilities to manufacture pharmaceutical
products that will meet U.S. GMP regulatory
requirements. These products may be offered to U.S.
companies as APIs or prepared for direct sale in the
U.S.
We will provide consulting services to help companies
to become compliant with U.S. GMP regulations. We
have expertise in the areas of drugs, biologics, active
pharmaceutical ingredients (APIs), and nutritional
supplements.
We can also provide GMP consulting to companies
wishing to sell products in Europe or in areas that
comply with European regulations.
companies with interests in China, most of our work
has come from companies in Asia (mainly China) who
wish to sell their products in the U.S. For that reason
we have concentrated on foreign companies, but we
would like to work with U.S. based companies as well.
We feel that we can offer valuable services and
insights to companies who wish to go to Asia to sell or
outsource products and intermediates.
We will work with companies located in Asia to prepare
them and their facilities to manufacture pharmaceutical
products that will meet U.S. GMP regulatory
requirements. These products may be offered to U.S.
companies as APIs or prepared for direct sale in the
U.S.
We will provide consulting services to help companies
to become compliant with U.S. GMP regulations. We
have expertise in the areas of drugs, biologics, active
pharmaceutical ingredients (APIs), and nutritional
supplements.
We can also provide GMP consulting to companies
wishing to sell products in Europe or in areas that
comply with European regulations.
For companies who are
new to the international
scene and wish to enter the
U.S. Market with API's;
we can help you to gain
credibility in the U.S. and
present yourself as an
organization that is capable
of passing a U.S. FDA
inspection.
This will be done through a
combination of auditing and
training, and a third party
check of your products.
If you are interested,
please contact us.
new to the international
scene and wish to enter the
U.S. Market with API's;
we can help you to gain
credibility in the U.S. and
present yourself as an
organization that is capable
of passing a U.S. FDA
inspection.
This will be done through a
combination of auditing and
training, and a third party
check of your products.
If you are interested,
please contact us.
| CHINA Dr. Kuwahara has a considerable amount of consulting experience in mainland China. Consequently we feel comfortable about offering our services to companies located in Taiwan, Hong Kong, Singapore or the People's Republic of China. In addition to Dr. Kuwahara, GXP BioTechnology can call on the expertise of a trained Chinese citizen. In addition to being fluent in Chinese, this individual is familiar with U.S. quality methods and the respective GMPs. As a member of the GXP BioTechnology team, this individual can provide follow-up support to Chinese companies as they proceed in developing their plans and facilities. Recently, Dr. Kuwahara and his associate, Simon Xiuwei Li, have translated the Chinese GMP and published an annotated version of these GMP. The book is entitled, "Chinese Drug GMP: An Unofficial Translation Including Related Sections of the Taiwanese, U.S., and ICH-API GMP." It was published in 2007 through the PDA (Bethesda, MD) and Davis Healthcare International (River Grove, IL, and is available through the PDA bookstore at: www.pda.org. |
| WHY ARE WE SO INTERESTED IN ASIA ? |
Dr. Kuwahara was born and
raised in Hawaii. Although
he is a third generation
American of Japanese
Ancestry (AJA, Sansei), like
many Asians from Hawaii, he
considers himself to be a
generic Asian. He suffers
from the fact that he cannot
read or speak any Asian
languages, but he grew up
in a community that
included Filipinos,
Japanese, Koreans,
Chinese and other people
from all parts of the Pacific
Rim. He is also quite familiar
with Pacific Islander culture
and food. As a result Dr.
Kuwahara is quite
comfortable at dealing with
Asians and Pacific Islanders
of all Nationalities.
raised in Hawaii. Although
he is a third generation
American of Japanese
Ancestry (AJA, Sansei), like
many Asians from Hawaii, he
considers himself to be a
generic Asian. He suffers
from the fact that he cannot
read or speak any Asian
languages, but he grew up
in a community that
included Filipinos,
Japanese, Koreans,
Chinese and other people
from all parts of the Pacific
Rim. He is also quite familiar
with Pacific Islander culture
and food. As a result Dr.
Kuwahara is quite
comfortable at dealing with
Asians and Pacific Islanders
of all Nationalities.
WORKING IN ASIA: Services to Asian Companies
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