Food and Beverage Compliance Services
Regulatory Support
At REJIMUS, our regulatory support services ensure that your dietary supplements and food and beverage products meet all FDA regulations from ingredient, to labeling to manufacturing and at the consumer end. We resolve FDA Warning Letters and Import Detentions, and ensure product compliance with federal standards. Our team assists in the preparation and submission of GRAS (Generally Recognized as Safe) and NDI (New Dietary Ingredient) notifications to the FDA, ensuring your products meet all safety and regulatory requirements. We provide expert review and guidance on product labeling and marketing claims to ensure compliance with FDA regulations and avoid misleading statements. Additionally, we implement systems to monitor, document, and report adverse events as required by the FDA, ensuring that your products adhere to all necessary safety and regulatory requirements. In the food and beverage industry, we offer expert guidance on FDA, FTC, and USDA labeling regulations and submissions. We also prepare for and respond to regulatory audits and provide comprehensive Recall Management services.
Quality Assurance and Quality Control
In terms of quality assurance, REJIMUS enhances your operations through our Best Compliance Practices™, implementing industry-leading practices to ensure your systems are compliant with all relevant regulations, including FSMA and FSVP requirements. Our team evaluates and optimizes your existing quality systems, ensuring your operations are efficient and compliant with industry standards. Additionally, we conduct Food cGood Manufacturing Practice (cGMP) audits to verify that your facilities meet all regulatory requirements, ensuring that your products are manufactured under the highest standards – not just paper checklist audits that do not suffice for GMP compliance upon FDA inspection. Any HACCP or HARPC Plan requirements are developed and implented to be done right the first time. For the food and beverage industry, we also support the design of facilities that comply with cGMP standards, handle facility registration with regulatory bodies, and provide ongoing support to ensure operational compliance. We implement systems to monitor and control environmental conditions in production areas and develop sanitation programs to maintain facility hygiene.
Product Compliance Development
For product development, REJIMUS supports the entire process of launching new dietary supplements and food and beverage products, from initial concept to market readiness. We provide expert assistance in product formulation, ensuring safety, efficacy, and regulatory compliance with 21 CFR Part 101 and 21 CFR Part 117. Our technical marketing support helps you effectively communicate the benefits and compliance of your products to consumers and stakeholders. We also advise on stability testing and shelf-life studies to ensure product quality over time, and assist in sourcing and verifying the quality and compliance of raw materials and ingredients used in your formulations. Our comprehensive support ensures that your new products are developed and launched successfully, meeting all necessary regulatory requirements.
Regulatory Intelligence and Strategy
REJIMUS offers regulatory intelligence and strategy services to keep you informed about changes in regulations and industry standards. Our team conducts regulatory landscape analysis to provide you with strategic advice for navigating the complex regulatory environment. We also conduct risk assessments and develop management strategies to mitigate regulatory risks, ensuring that your business remains compliant and can respond proactively to any regulatory challenges. Our goal is to help you stay ahead of regulatory changes and maintain compliance in a dynamic industry, including supply chain optimization and supplier qualifications.
Training and Education
At REJIMUS, we understand the importance of education in maintaining compliance and quality standards. We customized offer training programs on regulatory compliance requirements and best practices, ensuring that your staff is well-versed in the latest regulations and industry standards. Our training services equip your staff with the knowledge and skills they need to maintain compliance and quality, ensuring the success of your dietary supplement and food and beverage business.