Quality Assurance/Quality Control
(QA/QC)

Analytical Methods

As standards and protocols are developed for each step of production, from raw materials selection to finished product, procedures are carefully monitored in each production run to achieve the highest level of product consistency. In addition to measuring the level of characterizing components, the finished product of each batch is analyzed for the following characteristics:

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 BioScience 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 BioScience has undertaken research projects in both the US and China, including five human clinical trials, two human preclinical studies, nine safety studies, 12 in vivo lab studies, nine in vitro lab studies and four anti-doping studies.  The Company has collaborated with numerous research teams in CRO's in the US, major US universities, and some of China's top hospitals and institutes in order to implement the types of clinical studies that meet the highest standards in the international scientific community. The team that was initially responsible for the design and implementation of these studies involved academics from Harvard University's School of Public Health and scientists from the world of biotechnology to provide sound scientific research principles. 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 and the US 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.