| Claims Substantiation | Burdock Group | Burdock Group can work with your company to provide substantial scientific support for a claim or claims internationally, and submit your claim(s) to the proper regulatory authority or governmental bodies. In the U.S., Burdock Group can assist you to supp...veja mais Burdock Group can work with your company to provide substantial scientific support for a claim or claims internationally, and submit your claim(s) to the proper regulatory authority or governmental bodies. In the U.S., Burdock Group can assist you to support a nutrient content claims, structure/ function claims and health and qualified health claims. veja menos | |
| Color Additive Petitions | Burdock Group | Burdock Group can assist your company with a color additive petition that is submitted to FDA to request issuance of a regulation allowing new uses of the additive, and containing the necessary supporting data and information for a color additive for use ...veja mais Burdock Group can assist your company with a color additive petition that is submitted to FDA to request issuance of a regulation allowing new uses of the additive, and containing the necessary supporting data and information for a color additive for use in foods or cosmetics. veja menos | |
| Food (or Feed) Additive Petition | Burdock Group | Burdock Group can assist your company with a food or feed that is submitted to FDA to request issuance of a regulation allowing new uses of the additive, and containing the necessary supporting data and information for a food additive intended to have a t...veja mais Burdock Group can assist your company with a food or feed that is submitted to FDA to request issuance of a regulation allowing new uses of the additive, and containing the necessary supporting data and information for a food additive intended to have a technical effect in food. veja menos | |
| Generally Recognized as Safe (GRAS) Determinations | Burdock Group | Burdock Group can lead your ingredient or additive through the Generally Recognized as Safe (GRAS) process by which a substance is determined generally recognized, among experts qualified by scientific training and experience, to be safe under the conditi...veja mais Burdock Group can lead your ingredient or additive through the Generally Recognized as Safe (GRAS) process by which a substance is determined generally recognized, among experts qualified by scientific training and experience, to be safe under the conditions of their intended use. This GRAS determination can be self-affirmed, through a panel of experts, or Notified to FDA through the GRAS Notification process. veja menos | |
| Government Agency Representation | Burdock Group | Burdock Group has a long history of communication with the Food and Drug Administration (FDA), as well as the Center for Veterinary Medicine (CVM), the Federal Trade Commission (FTC) and the United States Department of Agriculture (USDA). We can get in to...veja mais Burdock Group has a long history of communication with the Food and Drug Administration (FDA), as well as the Center for Veterinary Medicine (CVM), the Federal Trade Commission (FTC) and the United States Department of Agriculture (USDA). We can get in touch with the right people to keep your project timeline intact, as well as schedule meetings and present information on your behalf. veja menos | |
| Label Reviews | Burdock Group | Burdock Group can provide an analysis of your product’s label to identify any gaps in compliance of that label in the country or countries that the product is being marketed. In the U.S., Burdock Group can give you an in-depth analysis of all substances o...veja mais Burdock Group can provide an analysis of your product’s label to identify any gaps in compliance of that label in the country or countries that the product is being marketed. In the U.S., Burdock Group can give you an in-depth analysis of all substances on your label and their regulatory status, the nutrition content, claims, and everything that you need to do in order to guarantee that your label is compliant with both Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations. veja menos | |
| New Dietary Ingredient Notifications (NDIN) | Burdock Group | Burdock Group can assist you with your filing for a New Dietary Ingredient (NDI). The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredi...veja mais Burdock Group can assist you with your filing for a New Dietary Ingredient (NDI). The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. veja menos | |
| Pre-Clinical Trial Design, Planning and Management | Burdock Group | Burdock Group can help you to design your pre-clinical trials to meet the necessary regulatory requirements for a safety or efficacy study. We will monitor and manage the study as it progresses, collect the data, summarize the information, as well as writ...veja mais Burdock Group can help you to design your pre-clinical trials to meet the necessary regulatory requirements for a safety or efficacy study. We will monitor and manage the study as it progresses, collect the data, summarize the information, as well as write a manuscript and submit the study for publication if needed. veja menos | |
| Regulatory Assessments | Burdock Group | Burdock Group can analyze your ingredient or substance and provide a regulatory assessment of the regulatory status of that substance in one or multiple international markets, as well as a gap analysis of the supporting data and information necessary for ...veja mais Burdock Group can analyze your ingredient or substance and provide a regulatory assessment of the regulatory status of that substance in one or multiple international markets, as well as a gap analysis of the supporting data and information necessary for regulatory approval of the substance in those market(s). veja menos | |
| Risk Assessments | Burdock Group | Burdock Group can save your company time and money by providing risk assessments for product distribution. Our expertise also allows us to step in and assess the risk of a contaminated FDA or USDA regulated product, potentially mitigating your lost revenu...veja mais Burdock Group can save your company time and money by providing risk assessments for product distribution. Our expertise also allows us to step in and assess the risk of a contaminated FDA or USDA regulated product, potentially mitigating your lost revenue for these products. veja menos | |
| Safety Assessments | Burdock Group | Burdock Group can analyze the safety of your substance throughout the scientific literature, and provide you with a safety assessment of data and information to support the safety of your substance in food, supplements, pet food, animal feed and cosmetics...veja mais Burdock Group can analyze the safety of your substance throughout the scientific literature, and provide you with a safety assessment of data and information to support the safety of your substance in food, supplements, pet food, animal feed and cosmetics products. veja menos | |
| Technical and Scientific Writing | Burdock Group | The Burdock Group team of scientists and research associates have extensive experience with researching, analyzing, writing and summarizing important scientific information into technical publications, such as manuscripts and monographs. |
