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Regulatory Affairs
Various government agencies regulate the food, cosmetic, dietary supplement, pharmaceutical and medical device industries. Regulatory affairs is the art of applying laws, regulations and policies to the development, production and sale of products in these industries.
Bioscience Translation & Application provides regulatory affairs services to ensure that your company and its products comply with all applicable regulations. Through our Liaison Services, we can help you with issues regarding your FDA or USDA-regulated product. We also provide guidance on the importation of regulated products into the United States.
Bioscience Translation & Application specializes in the following areas:
Food Industry
Cosmetic Industry
Dietary Supplement Industry
Pharmaceutical Industry
Medical Devices
Importing regulated products into the US
FDA Label Compliance
Website Compliance
Food Industry
Bioscience Translation & Application can help you develop & market your food product. From facility registration to label and marketing material compliance, we have the experience to ensure a successful product launch.
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 - does your product qualify for health or nutrient content claims?
Contact us for food industry services such as product development, GRAS determination, label evaluation, label production, technology / ingredient evaluation and organic certification.
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Cosmetic Industry
What ingredients are permitted? What testing is required? Are my labels compliant? 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 / ingredient evaluation and organic certification.
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Dietary Supplement Industry
Bioscience Translation & Application can help your company as regulation of the dietary supplement industry continues to evolve. As of December 22, 2007 the dietary supplement industry is required to report and keep record of adverse events.
Beginning in 2008, dietary supplement manufactures must comply with the Good Manufacturing Practices found in 21 CFR 111. 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.
Contact us for help with supplement labels, adverse event reporting, cGMP implementation, claim substantiation as well as product formulation and development.
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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. This includes products that are combinations of cosmetics and drugs.
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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Medical Devices
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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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.
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