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.
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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
Dietary Supplements & GMPs
Key Presentations (PDF Format)
