Here at REJIMUS, INC. we understand that regulatory compliance of all labeling aspects are critical to maintaining product safety, consumer trust, and business growth. We built the Panelgea® platform, which doesn’t just stop at providing automated facts panels in all formats possible that offer users “drop in” ready artwork to rapidly secure label approvals; we offer top tier regulatory consulting services to guide you and your team through all the complexities of labeling compliance, claims substantiation, and operational compliance for dietary supplements, food, and beverages.
Even with an advanced platform like Panelgea®, some challenges may require deeper expertise or even customization. We do NOT want you to get stuck or make a costly mistake. Whether it’s ensuring your product labels meet FDA or USDA regulations, responding to regulatory actions such as warning letters, or navigating complex supply chains, REJIMUS, INC. offers tailored solutions to meet your business’s unique needs, and help avoid costly labeling or testing mistakes from occurring in the future.
REJIMUS, INC. provides the most comprehensive label and packaging reviews for foods and beverages, dietary supplements, cosmetics, and OTC Drug products in the industry. Our reports are education for all departments from senior management all the way down to understand and ensure consistency in compliance, by enabling all reviewers to become more educated stakeholders.
Our Label Review reports bridge the gap between marketing creativity and regulatory compliance, ensuring your labels meet both creative and legal standards in the US Marketplace. We make it simple to submit labels and packaging for review of claims, specifications, formatting, and overall compliance. We don’t just point to problems or highlight non-compliance, we make it right where feasible and ensure you know why text or imagery can or cannot be used.
What sets REJIMUS apart is our ability to put forward compliant alternative language or refine your label text to get it right the first time. Our team also identifies potential ingredient or formulation issues early to help you avoid costly regulatory or legal challenges. This proactive approach accelerates your product’s path to market and gives you greater confidence in your brand’s compliance.
Substantiation of claims on food or dietary supplement labels shows a connection between a product and its benefits, but must be supported by solid scientific evidence. Misleading or false statements can violate state or federal consumer protection laws.
Drawing on extensive training over the past 15 years, and experience reviewing thousands of labels and writing thousands of claims dossiers, the Marketing Review Services (MRS) team at REJIMUS provides Claims Development and Claims Substantiation based on product formulations and qualified published studies. Claims Dossiers compiled by REJIMUS are the most comprehensive in the industry.
REJIMUS creates Claims Substantiation Dossiers offering detailed scientific and regulatory reviews of supporting literature for each claim, which then undergoes a secondary QA review before finalization. When a claim cannot be fully substantiated, alternative compliant language is provided where feasible. Simply having study references is not enough—each claim must undergo a thorough technical analysis to meet FDA requirements across all advertising channels.
REJIMUS helps companies establish raw new material and finished product specifications to ensure compliance, consistency, and integrity.
For raw material controls not at the Manufacturer level requiring Ingredient Specifications, REJIMUS developed the Ingredient Data Sheet (IDS), a controlled document that defines the characteristics of each ingredient, ensuring manufacturers cannot substitute suppliers without notice and that the ingredient documentation align, which is then defined in ones Quality Agreement. This protects product quality and label claims across production runs and vendors.
For finished products not at the Manufacturer level, REJIMUS created the Formulation Data Sheet (FDS) to help clients maintain GMP compliance and prevent unplanned changes to label claims, specifications, or even testing methods.
REJIMUS offers Regulatory Support that covers quality program design, optimization and strategy.
Helping companies develop or evaluate their Quality Units and better ensuring in-house quality system performance meets management expectation, transitioning between third-party labs, and manage vendor/vendor audits is routine for us.
Preventing or resolving regulatory inspection issues such as FDA Form 483s or Warning Letters is an area of deep expertise at REJIMUS, INC.
Ongoing support for Quality Control / Quality Assurance teams include review of testing protocols for raw materials, microbiological & chemical QC evaluations, review of SOPs, out-of-specification investigations, NCRs (non-conformance reports), facility audits, and establishing quality metrics.
Users on Panelgea’s annual subscription plan receive exclusive discounts on REJIMUS regulatory consulting services. By combining Panelgea’s automated solutions with the hands-on expertise of REJIMUS, you’ll ensure your compliance is is done right the first time, and save money while doing it.
With Panelgea, you get more than automation. We’re here to support you with expert regulatory advice to ensure that your product is fully compliant from start to finish, while offering flexible, affordable options.
For more information or to explore consulting packages, contact us today!
