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Regulatory Affairs
The Food and Drug Administration (FDA) has primary regulatory responsibility for the food, cosmetic, dietary supplement, pharmaceutical and medical device industries. In addition, regulations from various other agencies including the United States Department of Agriculture (USDA), the Consumer Product Safety Commission (CPSC) and the Federal Trade Commission (FTC) impact these industries. Regulatory affairs is the art of applying laws, regulations and policies to the development, production and sale of products in regulated industries.
Bioscience Translation & Application™ specializes in the following areas:
Food Industry Including Functional Foods
Cosmetic Industry
Dietary Supplement Industry
Wine, Distilled Spirits and Beer Labeling
Organic Product Labeling
Pharmaceutical Industry
Pet Food Industry
Medical Devices in the USA and EU
Tobacco Industry
Importing Regulated Products into the US
FDA Label Compliance
Website Compliance
Bioscience Translation & Application™ provides regulatory affairs services to ensure that your company and its products comply with applicable regulations. Through our Liaison Services, we can help you with issues regarding your FDA or USDA-regulated product by submitting questions to the agencies on your behalf and allowing your company to remain anonymous. We frequently provide evaluation of the best regulatory path for combination products subject to various sets of regulations. We also provide guidance on the importation of regulated products into the United States.
Unfortunately, some companies find us only after they have received warning letters, cyber letters or have had their products detained in customs due to failure to comply with FDA regulations. Bioscience Translation & Application™ has helped many companies respond appropriately to the agency, get out of trouble and stay out of trouble with our FDA Liaison and related services.
Food Industry Including Functional Foods
The regulation of food products is divided between the FDA and USDA. USDA generally has jurisdiction over meat, poultry and shell egg products, while FDA has responsibility for the rest of the food product market. These agencies administer regulations and policies to ensure that the food supply is safe and properly labeled. Food safety is assured in part by the inspection of food production and packing facilities as well as through guidance provided in regulations, the food code and consumer information.
Prior to introducing a food product into the marketplace, it is necessary to ensure the production facility is registered and adheres to applicable regulations. Some food ingredients must gain GRAS (Generally Regarded As Safe) approval prior to use in foods. It is also important to plan product marketing to ensure that the product developed meets marketing goals. Our nutritional analysis services can provide you with a nutrition facts box and help you determine whether your product qualifies for health or nutrient content, structure function or functional food claims.
The recently passed health care reform bill, the Patient Protection and Affordable Care Act, included previsions that all restaurants or vending machine companies with 20 or more locations must list nutritional information in menus or menu boards. Let us help you provide nutritional information to your customers.
Contact us for food industry services such as product development, GRAS determination, label evaluation, nutrition facts boxes, label production, technology and ingredient evaluation and organic certification.
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Cosmetic Industry
What ingredients are permitted? What testing is required? Are your labels compliant? What do the proposed changes to cosmetic regulations mean to your company? Should you register your facility and products? Bioscience Translation and Application™ can guide your cosmetic product development and marketing process to ensure that your products meet all safety and regulatory requirements.
Cosmetics are defined as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance". Some cosmetic products such as makeup containing sunscreen, fluoride toothpaste and dandruff shampoos are cosmetic-drug combination products and must also meet the regulatory requirements for over the counter drugs.
Contact us for cosmetic industry services such as product development, safety assessment, label production, label evaluation, technology and ingredient evaluation and organic certification.
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Wine, Distilled Spirits and Beer Labeling
FDA regulates the labeling of non-malt beers, wine coolers, hard ciders and other alcoholic beverages containing less than 7% alcohol. Labeling for these products must include full nutrition facts labeling.
The Alcohol Tobacco and Trade Bureau (TTB) is in the process of developing regulations requiring the labels of alcoholic beverages to include a serving facts panel. While regulations have not been finalized, manufacturers may voluntarily list such information provided that they follow published guidelines.
Get help with labels for your alcoholic beverages and learn what information to provide now and what is likely to be required in the future by contacting us today.
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Dietary Supplement Industry
Bioscience Translation & Application™ can help your company as regulation of the dietary supplement industry continues to evolve. Labeling requirements, including the need for a supplement facts box have been in effect since 1998. Since December 22, 2007 the dietary supplement industry is required to report and keep record of adverse events. Serious adverse events must be reported to FDA on MedWatch form 3500A within 15 business days of receipt of information on the adverse event.
Most dietary supplement manufactures must now comply with the Good Manufacturing Practices found in 21 CFR 111; by June 2010 even the smallest dietary supplement companies must comply with these regulations. Since the Dietary Supplement Health Education Act of 1994 became effective, supplement manufacturers have been responsible for determining whether their ingredients are permitted for use or if they are required to submit a New Dietary Ingredient notification. Manufactures must also submit all labeling claims to the FDA within 30 days of market introduction.
New dietary ingredients (NDIs) are those that were not marketed prior to October 15, 1994. New dietary ingredient notifications must be submitted to FDA 75 days prior to offering them for sale in the US.
Contact us for help with supplement labels, supplement facts boxes, adverse event reporting, cGMP implementation, claim substantiation as well as required submissions, product formulation and development.
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Organic Products
Foods, cosmetics and dietary supplements may be eligible for USDA certified organic labeling provided they comply with the National Organic Standards Program rules.
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Pharmaceutical Industry
Major regulatory sectors of the pharmaceutical industry include prescription drugs, generic drugs, orphan drugs and over the counter drugs. All new pharmaceuticals must be evaluated and approved by the FDA through the New Drug Application (NDA) Process.
Over the counter drugs must either conform to FDA monographs or undergo the NDA drug review process. OTC drugs have unique labeling requirements including the need for extensive drug facts boxes. This includes products that are combinations of cosmetics and drugs such as dandruff shampoo or combinations of cosmetics and medical devices, such as medicated bandages.
Homeopathic products are a special class of over the counter drugs and are regulated by FDA. The formulation of homeopathic products is covered by monographs covered in the Homeopathic Pharmacopeia of the United States.
Let Bioscience Translation & Application™ help you determine the appropriate regulatory route for your product. Contact us regarding your IND, NDA, drug facts or labeling.
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Pet Food Industry
Food and treat products for household pets are regulated by FDA. While not subject to premarket approval, pet foods must be safe to eat. Part of ensuring safety requires that the product be produced under sanitary conditions and contain no harmful substances. Pet food product labels must include an identity statement, net quantity statement, name and place of business of the manufacturer or distributor, and a list of all ingredients. Since several states also enforce their own labeling regulations, based on a model provided by the Association of American Feed Control Officials, it is very important to ensure that your pet food label complies with these guidelines also. Contact us today to ensure that your products meet FDA and AAFCO regulatory standards.
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Medical Devices - USA
Does your device require submission of a PMA or 510K? Bioscience Translation & Application can guide you through the medical device approval process. Contact us for help with your Class I, Class II or Class III medical device.
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Medical Devices - Europe
What is required to market your medical device in Europe? Our office in the Netherlands can help you ensure compliance with applicable directives. Contact us to prepare technical files, obtain CE marking, serve as your authorized representative and provide post market surveillance.
Our European office also provides design and validation services for sterilization & microbiology as well as Quality System audits for ISO 9001:2000 and ISO 13485. Contact our experts today.
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Tobacco Industry
Congress gave FDA statutory authority over tobacco products in 2009 with the passage of the Family Smoking Prevention and Tobacco Control Act. Tobacco manufacturing and holding facilities must be registered with FDA and all tobacco products must be listed with FDA by December of 2009. The ingredients in each tobacco product must also be listed with FDA. Learn more about these requirements by contacting us today.
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Importing regulated products into the United States
All imported FDA and USDA regulated products must comply with the same regulations as domestically produced products. Increased border inspections due to safety concerns have resulted in a growing number of products being held for improper labeling or failure to comply with FDA and USDA regulations. Bioscience Translation & Application can help you ensure that your product can be lawfully marketed in the US.
Most companies importing FDA-regulated products into the United States must have a U.S. agent that is physically located in the U.S. Bioscience Translation & Application is able to serve as your U.S. agent as required by FDA. Contact us for regulatory guidance for your imported product.
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