Natural Products Client Testimonials & Case Studies

Client: Kona Red

A company with an exciting new product needed to find the means of getting the technical side of things established.  The knowledge of their product was solid but disorganized.  Add to that the lack of in-house knowledge of the requirements for technical documentation, technical background and the desire to get the product quickly into the market and the opportunity to assist was obvious.

Objectives

Master technical specifications for the product

Set internal/external specifications for routine QC analysis

Establish marketing specifications for customer presentation

Complete training of the cGMP requirements and define needs for success

Results

Compliant documents generated

Implemented of successful, continued analytical evaluation criteria

Successful launch of products sold both domestically and internationally

Client: Brassica Concepts

Based on the work of a renowned scientist, the company had developed a product that captured the best of the output of the science behind the material.  The challenges were in the evaluation of both the technical aspects of the material, determination of status of the material from a regulatory perspective and ultimately ongoing technical evaluation of the material in conformance with applicable regulations.

Objectives

Complete regulatory evaluation of the material and its place in the regulatory realm

Create total package of technical documentation for use in-house

Complete technical specifications for the product used in analysis

Results

Completed technical specifications for the product in support of marketing efforts

Successful introduction of this new highly efficacious product with no regulatory risk

Client: Triple Diamond

A company wanting to import finished form dietary supplements into the US for successful marketing and sales.  The formulas were developed and sold internationally but not in the US.  The needs:  determination of the regulatory acceptability of the products, the ingredients, their claims and the labeling of the products.

Objectives

Complete regulatory evaluation of each product and all of their ingredients

Establish standards of testing criteria for all formulations

Results

Comprehensive compliant label copy for product intended for sale in the US region

Determined and presented of essential documentation to allow successful importation

Successfully launched products in the US market faster than anticipated