U.S. & INTL RETAILERS & DISTRIBUTORS
Quality Assurance & Control
Ingredient Verification Services
We can create the study design and protocols to manage the food lab testing with our partners to confirm label claims or presence of most other ingredients/actives. Work is done under confidentiality and managed by us through a third-party provider. Information is reviewed and released to you with interpretive commentary and related feedback.
Establishing Standard Operating Protocols (SOP’s)
If you are starting your own testing or Quality Program for manufacturing of dietary ingredients or finished products, we can support you not only on the general direction and most efficient strategy, but in the development of and implementation of all the critical stage SOP’s required for your business to be compliant. We can create custom SOP templates for Manufacturers, Laboratories, Research Facilities and Retailers within the Dietary Supplement Industry to quickly customize, enact and train your staff to get operational faster.
Quality Systems Analysis and 3rd-party Auditing
We can provide contract auditing services to inspect your provider to ensure that they are meeting current Dietary Supplement regulatory standards (under CFR 21 Part 111) and other regulatory guidelines. If you do not have the ability for on-site inspections or are in need of establishing your outsourcing program to qualified third-party providers, we can help.
REJIMUS is proud to offer the most comprehensive label reviews for food and dietary supplement labels in the industry. How do we know this? We’ve done our homework in order development the most cost-effective offering possible.
We offer an easy way to submit labels for review of claims, specifications, formatting and general compliance. What makes our service unique is that we’ll also provide you with what you can say on the label or actually augment the language so you can get it right the first time. While many companies offer label design and printing services, few have the expertise to review for compliance with the regulations. Additionally, we can identify ingredient or formulation issues that could potentially lead to costly regulatory or legal challenges down the road, affording you the option to revisit the product faster.
Enhanced Label Reviews evaluate:
• Label Presentation, Packaging and Position
• Nutrient and Supplement Fact Panel Issues or Errors
• Other critical supplement label issues and claims
• Requirements for Claim Substantiations
• Key regulatory considerations
• Identification of potential New Dietary Ingredients requiring notification
• Label Improvement and recommendations
For labels that have been previously submitted or evaluated, we can provide a quick confirmation of the respective changes to ensure your label is ready to go to print.
REJIMUS helps Food, Dietary Supplement, Cosmetic and Homeopathic companies achieve and maintain FTC and FDA compliance. Our team has expertise in manufacturing and production, litigation support, analytical testing, GMP auditing, supply chain qualification, label claims and technical marketing for natural products. Additionally, our custom build web-based project management system that allows us to track all work, deadlines and deliverables across multiple departments or locations worldwide to support the most demanding of complex regulatory programs with precision and scalability.
483 Form Observations and Warning Letters
We provide consulting for FTC actions, FDA Inspection, Form 483’s and Warning Letter responses as well as GMP compliance planning for 21 CFR Part 111, 110 and 101, as well as budgeting and guidance for restructuring of quality and regulatory operations. Whether we take the lead support of an FDA inspection to ensure future compliance including the hand-on writing of standard operating procedures (SOPs) and specifications, or close out investigations and adverse events, we have the scalability to meet the most demanding of deadlines.
Areas of support include:
• Dietary Supplement Consulting
• FDA Response Letters, CAPA Planning, Facility and Vendor GMP Audits
• Claim Substantiation, Website Content and Claims Reviews
• Product Development and Analytical Testing Strategy Support
• Quality Program Optimization and Gap Analysis
• Compliance Operations Planning & Implementation
• Formulation Data Sheets (FDS) and Ingredient Data Sheets (IDS)
• Quality Agreement for Laboratories, Manufacturers and Distributors
For law firms and attorneys that specialize in the Food, Diet Supplement and Homeopathic products, we have thorough reporting and documentation practices, in addition to regulatory and scientific expertise for litigation consulting on injunction relief, due diligence and infringement.
We provide law firms and/or in-house counsel with litigation consulting in all areas of Regulatory Affairs, Quality Assurance, Quality Control, Product Complaints, Formulation and Safety. Specific areas supported include scientific record keeping and facility auditing, investigation, off-label marketing reviews, formulation evaluation, contamination or adulteration issues and counterfeit products. All reports and data are presented in a litigation ready format.
REJIMUS provides Litigation Consulting and Expert Witness services for matters involving Food or Food Ingredients, Dietary Supplements, Dietary Ingredients, Cosmetics, Packaging, Homeopathic products and Medical Foods.
• Establishing Content, Use and Structure/Function Claims
• Label Misrepresentation or False Branding
• Breach of Contract or IP infringement support
• Regulatory Guidances & Interpretation
• Consumer Fraud or Adverse Events
• Expert Opinion
GMP, Quality & Regulatory Consulting
Our Litigation Consulting services for legal representatives address on-site or facility investigations, documentation reviews, SOP writing, corrective action planning (CAPA), quality system design and implementation as well as training for Quality or Regulatory departments.
• 483 Responses including GMP Gap Investigations and CAPA
• FDA Warning Letter Responses, SOP Writing and Training
• Compliance Investigations and Due Diligence
• Litigation Support for Injunction Relief or resolving a Consent Decree
• Direct oversight for Product Complaints, AERs, SAERs and Product Recalls
• Formulation Evaluations, Reverse Engineering Investigations
• General Regulatory, Quality and/or Scientific Consulting Strategy support