Contract Research Labs and Testing Labs

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The Fundamentals

Testing as a Business

If you are a contract lab testing finished products or raw materials for things like identity, purity/potency or known adulterants, we know the challenges you face day in and day out. The contract lab services business can get costly quick if not managed right and the potential for unplanned deviations is ever present, especially if you don’t know when the next wave of business will come or how to manage it more effectively. That being said, we’ve worked with some of the most profitable contract laboratories in the industries we service, to make them even more profitable, reduce wasteful operation, and most importantly grow strategically.

Laboratory Dynamics

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 Regarded 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.

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.

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 & 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.

FDA 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