New products and new compounds require new methods of analysis to support label claims, characterize materials for clinical studies or provide guidance for process development. A method of analysis is the complete set of instructions, from the sample preparation to the reporting of the results, required to conduct the analysis.

 

TBAR is a leader in analytical method development in the area of botanicals and dietary supplements. We strive to develop methods that are both reliable and practical, and can be transferred to other laboratories if necessary with minimal trouble. Many of the analytical methods developed by Dr. Roman have been adopted by AOAC, USP, INA and other analytical laboratories. Basic validation work will accompany any development project to provide confidence in the reliability of the results.

 

Our capabilities include HPLC with UV, PDA, fluorescence and evaporative light scattering detection, as well as GC-FID. In addition, through our partnerships with other laboratories, we can develop methods for HPLC or GC with MS and MS/MS detection.

 

Method validation is a systematic and well-defined process of demonstrating or confirming the performance characteristics of an analytical method. The key performance characteristics are accuracy and precision. Simply put, validation is demonstrating that the method is suitable for its intended purpose - a requirement of the current GMPs.

 

Nobody has more experience in method validation for dietary supplements than TBAR. Dr. Roman is author and instructor of several validation training courses, and is author or co-author on many published validation manuscripts, including ephedrine alkaloids (which is now the AOAC official method of analysis), biogenic amines in Citrus aurantium, chondroitin sulfate, coenzyme Q10, and others.

 

TBAR follows AOAC guidelines for single laboratory validations, which are the most rigorous and statistically based validation protocols of any organization.

 

If you would like to take your method to the next level of validation, Dr. Roman also has extensive experience designing and directing multi-laboratory collaborative studies, and is author and instructor for the AOAC training course on design and management of collaborative studies.

 

Providing accurate, reliable results for your product analysis is Tampa Bay Analytical Research's priority. We will guarantee the highest quality of data while providing competitive pricing and turnaround times. When we test your product, we will verify that the test method works on your product before we issue results. Inaccurate or meaningless results are worse than no results at all. We don't believe in "black box" methods, and all of our methods and data will be available for review.

 

The current GMPs place the onus of responsibility for supporting label claims on the manufacturer. We will ensure that you have the proper documentation for an audit, including the actual method of analysis (not just a journal reference) and raw data including chromatograms and copies of notebook pages if requested.

 

We can test your samples in accordance with AOAC Official Methods of Analysis, USP monographs, or other official monographs if so desired.

 

TBAR has extensive experience in method development, method validation, and quality systems, and shares that experience through training programs. In addition, we can come to your facility to offer customized hands-on training in any of these areas. Contact us for specific training programs to suit your needs.

With the passing of the GMPs and the increasing competitiveness of the dietary supplement market, there is an enhanced focus on product quality. The FDA is requiring it and consumers are demanding it. Quality cannot be tested into a product, but must be built into the product from the beginning. It is impossible to guarantee consistent quality product with inadequate, unsuitable, or inappropriate testing and control procedures in place. Tampa Bay Analytical Research offers numerous consulting services to help ensure your company has all the tools available to manufacture high quality, consistent products, including:

 

• Analytical Method Validation Protocol Development

• Statistical Analysis of Validation Data

• Reviewing Label Claims and Advertising

• SOP Writing/Review

• Quality System Assessments

• Laboratory Audits

 

Contact us to find out how we can help you raise the bar on product quality while gaining a competitive edge.

TBAR can provide expert testimony and litigation support on analytical methodologies and data analysis in support of litigation. With government recognized expertise in the fields of dietary supplement analysis, analytical method development, validation, and quality systems, TBAR can offer unbiased and professional evaluations to resolve disputes involving quality assessments of your product, conflicting laboratory results, and patent infringements. Please contact us for more information on how we can assist with your litigation needs.