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Comprehensive

& Conscientious

Product Manufacturing

Science & Research First

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We are committed to the goal of producing the most effective and therapeutic nutritional products possible. We are keenly aware of the responsibility this entails and have distilled the concepts that are essential to meeting this goal into our motto: "Science and Research First."

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These “Science and Research First” concepts include, but are not limited to, raw ingredient selection, product formulation and potency decisions, dietary recommendations, and marketing messages. From raw material selection through manufacturing, to shipping of the finished product, we adhere to the strictest of quality control standards. Every step of the process is thoroughly controlled and closely monitored.

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Our products are formulated based on the latest nutritional science to ensure appropriate potencies and optimal combinations for absorption, utility and effectiveness.

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Raw ingredient Selection:

Our comprehensive evaluation criteria are designed to corroborate all aspects affecting quality and efficacy of the raw ingredient, specifically:

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  • Identity

  • Purity

  • Quality

  • Strength

  • Composition

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Potency testing and botanical identification using internationally validated methodologies: AOAC (Association of Analytical Communities), HPLC (High Performance Layer Chromatography), FTIR (Fourier Transform Infrared Spectroscopy) and HPTLC (High Performance Thin Layer Chromatography).

 

 

Our product development experts follow the latest research to ensure that we are using the finest raw ingredients available.

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Synergistic Formulations

We take much pride in our “Science and Research First” approach to the development of highly effective synergistic formulations. Synergies exist for many combinations of nutrients, and our formulas take full advantage of this principle. We offer numerous formulas containing synergistic groups of nutrients that satisfy the therapeutic goals for various deficiency states and conditions.

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Our development experts employ a holistic approach, always taking into account the complexity of human metabolic pathways. When formulating a complex array of nutrients, we always review the complete clinical picture to avoid, for example, metabolic imbalances caused by high doses of one particular nutrient. In addition to their inherent benefits, synergistic formulas often enhance patient compliance by minimizing the number of supplements a patient is asked to consume.

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Comprehensive Manufacturing Services:

To meet strict quality program requirements, FDA and other regulatory guidelines, we utilize a combination of on-site and third party laboratories.

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  • Full on-site microbiology lab

  • Methods to test aerobic counts, anaerobic counts, yeast and mold counts and pathogen screens for e-coli, staph and salmonella

  • Method development capabilities

  • Identity testing capabilities (Fourier transform infrared spectroscopy)

  • Complete analytical screening of all raw materials and finished goods

  • Independent third party residual solvent screens

  • Potency verifications and pesticides tested at analytical lab via High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC)

  • Independent third party heavy metals analysis via Inductively coupled plasma mass spectrometry (ICP-MS)

  • Complete batch and testing records for each lot of material produced

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A Commitment to Quality

All products are manufactured in the facilities that are FDA registered and GMP certified, as well as NSF certified. Our stringent quality control processes and procedures are in place to ensure the products manufactured meet label claims and rigorous specifications for purity, strength, and composition.

Quality Process:

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  • Complete screening of all raw materials for identity, potency, heavy metals, pesticide screens and microbial contamination

  • Segregation of raw materials until testing is complete

  • Complete traceability from raw material receipt through finished batch completion

  • Specifications and master batch records for all finished goods to ensure process repeatability

  • Analytical testing to ensure label claims are met

  • In-process inspections to ensure uniformity that conforms to specifications throughout the batch

  • Final inspection and release of all finished goods. Testing results for each lot are compiled in Certificates of Analysis

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OUR MISSION

Our mission is to advance products with proven science by providing

the top clinical trial, clinical study, basic science research, medical

writing and consulting services to the natural nutrition products industry.

OUR VALUES

We are passionate about science, research, medicine and nutrition. We apply our passion and professionalism to everything we do. Accuracy and rigor are cornerstones of our business, and we are committed to delivering careful and meticulous work for our customers.

 

We value a team-oriented approach and focus on building and maintaining long-term relationships with our clients, investigators,

and clinical sites to create sustainable alliances.

© 2017  Medical Nutrition Research and Development Enterprise of America

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