PRIVATE LABEL & CONTRACT MANUFACTURERS
For Private Labelers and Contract Manufacturers of finished products in the Foods, Animal Feed, Dietary Supplements and Cosmetic industries, the impacts of the GMP regulations are ever present. And by the end of 2016, FSMA regulations are going to take shape with aggressive regulatory enforcement on Food and Supplement companies. Whether building a new manufacturing facility from the ground up, implementing a new quality documentation system, expanding to international markets or optimizing your existing quality and production operations, we have experts that can guide at every stage of your business.
For Raw Material Ingredients
Knowing what your product contains and ensuring label claims are met is not only good business – it is a FDA regulatory requirement. We provide the most meaningful outline for specifications of raw materials and other particular ingredient information in a customized Ingredient Data Sheet (IDS). For finished products we provide a highly detailed Formulation Data Sheet (FDS) that outlines the critical characteristics as they relate to the intended purpose of a formulation and the ingredients therein.
Applying a multi-layered approach, the IDS’s outline various characteristics into meaningful specifications for use in controlled sourcing of the materials for ongoing production. We can help identify the characteristics of the materials you want that are critical to the given formulation. Why is this important? Toll Manufacturers and Private Label Manufacturers can interchange ingredients from different suppliers during the course of production to optimize production and profitability without notice, unless a Quality Agreement is in place. This can directly impact the quality and consistency of your finished product.
• NDI – New Dietary Ingredient
Do you have a New Dietary Ingredient (NDI) to file with the FDA? Are you sure you need to file an NDI? There are some exceptions. We can assist in the review, preparation and submission of your NDI with greater success. Typical turn-around times are 4 to 6 weeks.
• GRAS – Generally Recognized as Safe
For a Self-affirmed GRAS Notification or use of an Expert Panel to review, we can assist with the development, management and submission of a GRAS dossier to the FDA, from start to finish.
For Finished Products
During and after dietary supplement manufacturing, a means of assessing the consistency as well as that the finished products meet specifications are required by the FDA. Regardless of the dosage form of the finished product, there are critical characteristics or parameters that must be identified and controlled for. Knowing what finished product specifications are in an FDS is critical and establishing those criteria for either in-house or outsourced resource to continually produce are essential for GMP compliance.
Formulation Data Sheet – A Formulation Data Sheet (FDS) is a controlled document that identifies all of the parameters and acceptance criteria for a given formulation, as defined by the owner of a given formulation such that the product can be produced reliably and be upheld to the standards of production. This document is not the same as a Specification Sheet for the given formulation.
Ingredient Data Sheet – An Ingredient Data Sheet (IDS) is a controlled document that identifies all the parameters and acceptance criteria for a given ingredient, including all ingredient sources, as defined by the owner of a given formulation to which the ingredient may be included, such that the end product can be produced reliably and be upheld to the standards of production. This document is not the same as Certificate of Analysis or Specification Sheet for the given ingredient.
Quality Assurance & Quality 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.
Supplement Facts and Labeling
One of the most vital pieces of your product formulation is the label information. This is highlighted in either a Supplement Facts panel or a Nutrition Facts panel. There are specific requirements outlined by regulation for every aspect of your label.
We provide expertise in label reviews and claim development that conforms with regulations including structure, type size, nomenclature and layout. However, what you also receive in our Label Reviews is insight into the regulations. There are many chances to get this information wrong or improperly interpreted by designers and manufacturers, but we make sure it is done right.
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.
For labels that have been previously evaluated only, we can provide an add-on service to make the actual required changes to your labeling and packaging artwork, so it is compliant and print ready. See Label Remediation for more information.
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
NDI and GRAS
NDI – New Dietary Ingredient
Do you have a finished product with a New Dietary Ingredient that requires notification to the FDA? Are you sure you need to file an NDI or could your product be considered an Old Dietary Ingredient or ODI? What are the NDI Notification (NDIN) requirements? There are some exceptions to know about. We can assist in the review, preparation and submission of your NDI with greater success.
New Dietary Ingredient Notification filing services include:
• Reviewing the historical use and safety of the ingredient
• Literature reviews and analysis of all scientific data, protocols and supporting documentation
• NDI packet preparation and submission to FDA with Response Support
• Dedicated Project Management Platform with Client side access
GRAS – Generally Recognized as Safe
For traditional Food and Beverage products, you are going to need to ensure your ingredients are GRAS. A Self-affirmed GRAS with an Expert Panel to review a GRAS dossier and the requirements, are things we can assist with in all aspects of the development, management and submission to the FDA, from start to finish.
GRAS Self-determined or Notification Services include:
• Assessing ingredient development and regulatory strategies and requirements
• Literature reviews and research inclusive of all scientific data, protocols and supporting documentation
• Toxicological study and data reviews
• GRAS dossier preparation for either Self-affirmation or Expert Panel Review (including Panel Assembly and Moderation)
• GRAS notification submission to the FDA and Response Support (optional)
• Dedicated Project Management Platform with Client side access