At NSF-DBA, we can provide customized testing services, including method development and validation, bioanalytical support for clinical trials and performance and stability services to meet your company’s immediate and future needs.

Our capabilities include:

• Method development
• Stability Storage and Testing Solutions
• Bioanalytical Testing Services for Clinical Studies

Our laboratory staff has extensive experience in developing new methods specific to complex dietary supplement matrices, including herbal blends, nutritional bars and beverages. Since early 2005, NSF-DBA’s laboratory staff has developed more than 120 new dietary supplement testing methods. NSF-DBA has the tools, techniques and experience to adapt preparation techniques, enhance separation approaches and create a method that is customized to the analytical problem at hand.

NSF-DBA scientists are experienced at handling unique requests. Our processes for development are efficient and our quality practices ensure that the techniques are scientifically valid and designed to best meet the customer’s needs.

Storage

NSF-DBA's laboratories possess qualified stability chambers, whose conditions are compliant with standard Zone I-IV International Conference on Harmonization (ICH) guidelines:

• Refrigerated: 5 + 3°C
• Room Temperature: 25 + 2°C, 60 + 5% Relative Humidity (RH)
• Intermediate: 30 + 2°C, 65 + 5% RH
• 40 + 2°C, 75 + 5% RH

Stability Testing

Through our facilitation of a dietary supplement industry work group, NSF-DBA helped to develop a guideline for industry that would provide it with tools for conducting stability studies and implementing stability programs in their operations. NSF-DBA can assist companies substantiate their products' shelf life through monitored storage of samples, testing for contaminants or against label claims during a stability study, or designing a stability study to be conducted at a facility. With our storage and stability testing capabilities, we are well positioned to offer testing for all types of products, including dietary ingredients and finished dietary supplements as well as be able to conduct long-term and accelerated stability studies. Our expert scientific staff can also provide assistance with identifying appropriate FDA-compliant sampling strategies and defining and developing appropriate stability-indicating assays.

NSF-DBA's laboratory staff has expertise in analyzing dietary ingredients and other compounds in a variety of biological matrices (e.g., urine, plasma) as bioanalytical support to a clinical study. Our extensive scientific staff and continual investment in new technologies allows us to be a leader offering cutting-edge testing to the dietary supplement industry. Our network of clinical and pharmacokinetic experts can assist in the design and support of a clinical study to substantiate your claims.

NSF-DBA consultants can provide a regulatory review of product labels to domestic and international requirements. Domestic label reviews ensure compliance to FDA, Federal Trade Commission and Dietary Supplement Health and Education Act of 1994 requirements. Reviews against international regulations can also be conducted to ensure products' labels compliance prior to going to market.

• New Dietary Ingredient (NDI) Notifications:
  If a company is planning to use an ingredient that was not marketed in the United States in a product prior to October 1994, the FDA requires that the company submit a safety assessment (NDI Notification) verifying that the ingredient is safe for human use. This includes a review of the product use history and safety studies, development of toxicology data as appropriate, and preparation and submission of the NDI Notification.
• GRAS (Generally Recognized as Safe) Dossiers
  Preparation of regulatory submissions or self-affirmation, as appropriate. Compilation of the necessary documentation based on generally available safety data and information about the use and manufacture of the substance. Co-ordination of an expert panel to determine whether there is consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use.
• Botanical Risk Assessments
  Review of available toxicological information and history of use for a botanical substance to determine its safety.