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FAQs - Heterogeneity, LLC
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WherE regulation Meets the Real World. Frequently asked questions (FAQs). 1 What are "Natural Health Products" (NHPs)? 2 How are Natural Health Products regulated in the United States and in Canada? 3 What is a "botanical"? 4 What is a "dietary supplement"? 5 What is a probiotic? 6 When is a probiotic considered to be a "live biotherapeutic product"? 7 When is an Investigational New Drug required to be filed with FDA? How can HG help? 1 What are "natural health products" (NHPs)? Return t . Intended use ...
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Whole Elephant - Heterogeneity, LLC
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Is greater than the parts. Whole Elephant" Approach to Product Development. No aspect of product development should be conducted in . Isolation. Each part is integral to the entire project. Each part sho . Uld fit an overall plan. Yet many development programs suffer from "Six Blind Men" syndrome. Various elements of the program proceed without adequate interaction from the other members of the project team. Ailing program - as no one has the "big picture.". It was six men of Indostan. R Exp . HeteroG...
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Servicios 2 - HeteroGeneity, LLC - Spanish
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REGULADORA. POLÍTICA. CIENCIA. ESTRATEGIA. COMO PUEDE HG ASISTIRLE? Su próxima idea de un producto! Desarrollando un plan regulatorio para el programa de desarrollo de su producto. Determinando lo que le falta al expediente actual de su producto. Haciendo promociones legales de sus productos. Respondiendo “deficiencias” identificadas por las agencias reguladoras acerca de las instalaciones de sus fabricas y otras instancias. Aprenda a proteger su producto de el de sus competidores. COMO PUEDE HG ASISTIRL...
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Servicios - HeteroGeneity, LLC - Spanish
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Somos líderes en el campo del desarrollo de productos naturales complejos. HG ofrece servicios a la industria regulada en los Estados Unidos y Canada. Nuestros servicios abarcan todo el proceso de desarrollo desde la concepción del producto y el análisis objetivo de los datos, no-clínicos y clínicos hasta las estrategias de mercadeo y post-comercialización. Evaluación y Análisis de documentos e identificación de fallas en los expedientes. Estrategias sobre Propiedad Intelectual. Identificación de ...
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News - Heterogeneity, LLC
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FDA Approves Crofelemer as First-Ever Oral Botanical Drug. Marking the second time a botanical has received drug approval from the Administration. FDA Approves Special Green Tea Extract as a New Topical Drug for Genital Warts. Expert Says Development Marks the Birth of a “New Industry”. HeteroGeneity, LLC,. A Washington, D.C.-based consulting firm advising companies seeking to market botanically-based drugs.". 65279; . How can HG help? Http:/ www.heterogeneity-LLC.com. 5611 16th St. NW.
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Publications - Heterogeneity, LLC
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Regulation of healthcare products in the united states. Botanicals as "New" drugs: US development. Epilepsy and Behavior: 2015, pp. 338-343. Botanicals are ingredients that can be marketed as goods, drugs, cosmetics, and medical devices in the United States. When a botanical is intended to diagnose, treat, prevent, mitigate, or cure a disease, it is considered to be a "drug." This article is reviews the US regulatory requirements for botanicals as "new" drugs.". HerbalEGram: Volume 10, Number 6, June 2013.
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Our Focus - Heterogeneity, LLC
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HG assists organizations involved in healthcare product-related research, development, and commercialization. Working with both start-ups and well-established organizations, HG provides an independent source of professional, regulatory and technical expertise not generally available in-house or at a single institution. HG develops and directs teams based on the needs and scope of the project. Working together HG can address a broad range of product development scenarios. Working closely with associates w...
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Events - Heterogeneity, LLC
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Upcoming events where Heterogeneity Is Participating. The Fourth Latin American Congress of Phytotherapy. September 1 - 6, 2015, Peru. 18th Presidential Commission for the Study of Bioethical Issues. August 20, 2014, Washington, D.C. The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its eighteenth meeting on August 20, 2014. At this meeting, the Commission will discuss the BRAIN Initiative and ongoing work in neuroscience.". Events prior to 2014. 65279; .
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Services - Heterogeneity, LLC
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Regulatory.Policy.Science.Strategy. We are leaders in the field of complex, natural product development. G offers services to . The indu . Stries regulated by the . States and C . Our services span the development process from product conception and target analysis, nonclinical, clinical, and post-marketing strategies. We review, assess and actively manage the raw material, nonclinical, clinical, regulatory processes. We conduct compliance assessments regarding "GXPs". Fish and Marine Oils.
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Services 2 - Heterogeneity, LLC
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Regulatory. Policy. Science. Strategy. Heterogeneity can assist you to:. Your next product idea! Develop a regulatory plan for your product development program. Determine what is missing from your current product dossier. Make legal product promotional claims. Address regulatory "deficiency" letters regarding your manufacturing facilities. Understand the differences between scientific research versus product development. Learn how to protect your product from competitors. Know what NOT to patent.