Quality Assurance/Quality Control
|
 Texture |
Plant
Identification (TLC) |
Heavy
Metals |
| Color |
Extraction
Yield |
E. coli |
| Odor |
Foreign
Matter |
Salmonella
spp. |
| Taste |
Total Ash |
Total Bacteria
(plate count) |
A Certificate of Analysis verifying the above characteristics is provided
with each batch of finished product. A product sample from each production
run is kept in storage and analyzed on a regular schedule in order to
monitor quality, potency and shelf life characteristics.
HPLC Fingerprints
The PhytoMedical Research references all extracts to a proprietary
database of HPLC fingerprints to ensure that a complete array of chemical
components are present and represented in each batch of raw materials
used as well as the final extract material.
PRODUCT RESEARCH AND DEVELOPMENT
Preclinical and Clinical Testing - Botanica has experience in managing
every stage of product development, from formula concept and ingredient
standardization to clinical studies on finished products. Each phase
of product development is designed to raise the level of consumer and/or
regulatory acceptance of products developed by Botanica BioScience.
We are willing to consider assisting other companies with any or all
of these product development phases.
Safety Testing
An important difference between evaluating herbal product safety and
the safety of new drugs is the extensive historical precedent supporting
the proper use of most medicinal herbs. Although safety studies are
uncommon in the herb industry, the prudent approach in protecting the
credibility and liability exposure of a company is to provide clear
evidence of product safety. The standardized single herbs have varying
degrees of safety data available, in addition to perhaps two thousand
years of safe human use. Most of the recent safety data was derived
from laboratory studies conducted in China on single herbs, and from
human clinical data developed in conjunction with Botanica's clinical
trials program. Human safety data is derived as part of the clinical
data set collected by Botanica's clinical trials teams in China. In
addition, Botanica has developed a collaboration for implementation
of western-standard toxicology studies in Beijing. These studies provide
assurance of product safety at a substantially lower cost than that
of similar studies performed in the U.S.
Efficacy Testing
Botanica has established and trained several clinical trials teams
in some of China's top hospitals to implement the types of clinical
studies that meet the highest standards in the international scientific
community. The responsibility for the design and implementation of these
studies rests with a professional clinical trials team headed by Botanica's
Chief Scientific Counsel, Peter Goldman, MD, of Chair Emeritus of Harvard
University's Clinical Pharmacology Program and the Nutrition Program
at Harvard's School of Public Health. Dr. Goldman is directly involved
in ensuring that the data developed is based on sound research principles.
Botanica's research is also directed by Richard C. Honour, PhD, who
has been involved in clinical research, biotechnology and pharmaceutical
development for more than twenty years. Botanica's Director of Product
Research and Development in China, Wang Ruotao, MD, PhD, is one of the
country's most knowledgeable resources regarding international standards
for clinical research and epidemiology. Botanica research conducted
in China has been accepted as valid substantiation for herbal product
claims made in the US market by the National Advertising Division of
the US Council for Better Business.
Once a product has been proven effective in Chinese clinical studies,
Botanica can facilitate U.S. based research studies to further strengthen
the marketability and acceptance of its clinical research. U.S. studies
are designed and executed in collaboration with leading experts in the
particular field of research.
© 2000-2004 Botanica BioScience Corporation
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