CRO/Research Consulting

Analytical and Specialty Research

At AIBMR Life Sciences, we offer a variety of research services to investigate the quality, identity, purity, and stability of natural products and dietary supplements such as:

We believe that performing well planned analytical research is an important part of every QC program and supports the integrity in the manufacturing of natural products. As we all know, this has become critically important as the media continues to make us aware of the problem with contamination of natural products with adulterants such as melamine and even active pharmaceuticals.
With the recent implementation of cGMP guidelines for dietary supplements this type of assurance is is no longer a choice, but rather a necessity.

AIBMR Life Sciences analytical research services can benefit your company by guiding you through the proper course of research, whether it be for cGMP compliance or just to better understand your products’ physical properties.

The New cGMP Rule—A Mandate for QC

Quality assurance is fundamental to cGMP compliance, and the new cGMP rule defines “quality” to mean that a dietary supplement meets established specifications for identity, purity, strength and composition. Specifications must also be set and met for limits on contaminants, such as heavy metals, solvent residues and harmful microorganisms, in finished products.

This means that laboratory analysis of both raw materials and finished products is in integral part of the production process. The rule devotes an entire subpart to requirements for operation of an analytical laboratory. As stated in the rule, “laboratory facilities must be adequate to perform whatever tests and examinations are necessary” to determine if specifications are met for raw materials, materials in process and finished products.

Services