Our consultants are cGMP and regulatory experts for the Food, Dietary Supplement, OTC Drugs, Pharmaceutical, and Hemp/CBD industries. We facilitate the implementation of technical and legal requirements utilizing our vast knowledge and resources, that companies may have difficulty fulfilling. We provide support in areas such as product development, labeling, quality assurance, quality systems implementation, regulatory compliance, SOP development, document control, auditing, expert witness, recalls, and 483/warning letter remediation. JQMS also serves the industry as US agents for FSVP regulations.
The auditing services we provide will ensure that your products and facilities are in compliance with GMP standards and other regulations that will keep your products in the marketplace. JQMS conducts thorough GMP audits to assess your level of compliance. We then provide a detailed report, reviewing the audit findings, and assisting with the development of the corrective and preventive action programs. Our comprehensive program will help you develop strategies that ensure full compliance moving forward.
JQMS offers valuable, high-quality training courses that will help you gain beneficial knowledge and information on expectations for FDA regulated industries. Our courses are led by our regulatory experts and certified lead instructors, who are qualified to evaluate and determine all your training needs. We offer a variety of course delivery options such as in-house training, seminar style, as well as web-based e-courses to fit your specific scheduling needs. Training topics include but are not limited to, cGMPs (for 111, 117, 210/211), FSVP, Preventive Controls (PCQI), Intentional Adulteration, and training on Standard Operating Procedures (SOPS).
Form 483 and Warning Letter Remediation
At the end of an FDA investigation, a Form 483 may be issued. Form 483s identify potential regulatory problems and violations which can deem your products adulterated or unsafe for use. Companies are required to respond to the 483 in a timely manner outlining their corrective action plan and must put this plan into action expeditiously. If the violations are deemed serious or your 483 response is inadequate, an FDA Warning Letter is likely to follow. If a form 483 form or warning letter is issued, it is crucial to respond with the proposed strategy within 15 days of receipt. Our experts will help to ensure that your response is timely, detailed, and thorough. The corrective action plan will include all necessary requirements to bring you into compliance and avoid further enforcement actions by FDA.
Product Development and Labeling
Product labels are the main source of information available to distributors and consumers regarding your product. It is important that the label information and product claims are accurate, truthful, and not misleading. Your product development must be based on safe, legal ingredients and meet regulatory requirements before the product is introduced into the marketplace. JQMS provides guidance and review of your formulations and labeling to ensure FDA and FTC regulations are being followed.
When a product is recalled, it means that the product is found to be defective or has potentially raised safety concerns. If addressed correctly, recalls can result in a decline in sales and can ruin a company’s reputation. JQMS will help you develop a recall program to ensure you are ready and can act quickly should a recall become necessary. Recall procedures, mock recall exercises, and readiness assessments are included in our recall assistance program.
Regulated industries frequently subjected to compliance and regulatory disputes. Industry standards and practices are generally very technical and complex. Specialists in the field are often called upon for their expertise to provide reliable and dependable opinions.
Our consultants can serve as expert witnesses with the required specialized skill sets needed to form factual opinions and testimonies. Our expert witnesses are informed and knowledgeable in industry standards and regulations. They can help defend a company against issues such as health claims lawsuits, food labeling litigations, and manufacturing regulatory legalities, among other relevant legal issues.
US Agent and Imports
JQMS can serve as the U.S. agent for a foreign establishment wishing to import food products into the United States. We will assist and facilitate communications with the FDA, develop and administer the foreign supplier verification program (FSVP), and aid in coordinating FDA FSVP inspections. JQMS will assess regulatory compliance of the imported products and assure that your product is ready for distribution in the United States.
Food Safety Modernization Act (FSMA)
The Food Safety Modernization Act (FSMA) was put into effect in 2011 and was designed to protect US consumers and prevent foodborne illnesses. It emphasizes clear steps and specific actions that must be followed to ensure that a safe food supply is distributed within U.S. markets. JQMS assists food suppliers by making sure that they are in compliance with the Food Safety Modernization Act. FDA has been mandated by FSMA to issue several new rules to protect the food supply. It is incumbent upon the industry to stay ahead of the changes. For food manufacturers, we provide education and assistance with preventive controls for human food, to mitigate or prevent food hazards during production. For those importing products from foreign producers, we provide Foreign Supplier Verification Programs (FSVP) to ensure that foreign imports were produced and manufactured under the same set of standards as domestically produced foods. As FDA issues the new rules let us help you stay a step ahead.