Dietary Supplement Compliance Services
Regulatory Support
At REJIMUS, our regulatory support services ensure that your dietary supplements meet all FDA regulations. We resolve FDA Warning Letters, Form 483’s and Import Detentions, ensuring product compliance with federal standards. Our team is a leading authority in the preparation and submission of GRAS (Generally Recognized as Safe) and NDI (New Dietary Ingredient) Notifications to the FDA, ensuring your ingredients 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.
Quality Assurance
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 under 21 CFR Part 101 and 21 CFR Part 111. Our team evaluates and optimizes your existing quality systems, ensuring your operations are efficient and compliant with industry standards. Additionally, we conduct Good Manufacturing Practice (GMP) audits to verify that your facilities meet all regulatory requirements, ensuring that your products are manufactured under the highest standards.
Product Development Compliance
For product development, REJIMUS supports the entire process of launching new dietary supplements, from initial concept to market readiness. We provide expert assistance in product formulation, ensuring safety, efficacy, and regulatory compliance. Our technical marketing support helps you effectively communicate the benefits and compliance of your products to consumers and stakeholders. We also provide guidance 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.
Regulatory Intelligence and Strategy for Dietary Supplements
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.
cGMP Training and Education
At REJIMUS, we understand the importance of education in maintaining compliance and quality standards. We offer training programs on regulatory compliance requirements and best practices, ensuring that your staff is well-versed in the latest regulations and industry standards under 21 CFR Part 101 and Part 111. Our quality management systems training provides guidance on the implementation and maintenance of effective quality management systems, helping your team uphold high standards in every aspect of your operations. 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 business.