MARKETING & DIRECT RESPONSE
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.
Label & Packaging Reviews
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
Confirmatory Label Reviews
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.
As an alternative to providing a Confirmatory Review during the same standard turn-around time of an ELR, we can provide the corrections on the label design directly to help potentially save extensive time from repeated edits or changes concerned with compliance.
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