pharmacro.com
PharMacroMedical device, drug and combination medical products development
http://www.pharmacro.com/
Medical device, drug and combination medical products development
http://www.pharmacro.com/
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Domains By Proxy, LLC
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United States
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Domains By Proxy, LLC
Registration Private
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14747 N Norths●●●●●●●●●●●●●●e 111, PMB 309
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United States
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PharMacro | pharmacro.com Reviews
https://pharmacro.com
Medical device, drug and combination medical products development
pharmacro.com
Resources at PharMacro
http://www.pharmacro.com/resources
Overview of Medical Device Regulations. Overview of IVD Regulations. QSR Good Manufacturing Practices (Medical Devices). 510(k) database and search. Medical Device Guidance documents. Clinical Laboratory Improvement Act (CLIA) database. Investigational Device Exemption (IDE). Global Harmonizing Task Force (GHTF). Drugs and Combination Products. New Drug Application (NDA) Process. Office of Combination Products. FDA’s Critical Path Initiative. Inactive Ingredient Search for Approved Drug Products.
Development of an automatic, non-invasive continuous glucose monitoring system at PharMacro
http://www.pharmacro.com/projects/noninvasive_glucose_monitoring-system
Development of an automatic, non-invasive continuous glucose monitoring system. Cygnus Inc had demonstrated feasibility of continuous glucose monitoring using reverse iontophoresis to extract interstitial fluid across the skin. As Vice President of Engineering, Dr Soni was assigned the responsibility of developing the sensor design, manufacturing process and custom equipment for the manufacture of the GlucoWatch sensor. Product Designation by the Office of Combination Products (OCP) – Perils.
Development of an inhaler (combination product) for the treatment of asthma and COPD at PharMacro
http://www.pharmacro.com/projects/inhaler_for_asthma_and_copd
Development of an inhaler (combination product) for the treatment of asthma and COPD. A multi-national company with expertise in generic products had identified an opportunity for developing a branded inhaled drug delivery system for the treatment of asthma and COPD. PharMacro was brought in to help develop the regulatory strategy and to provide leadership on formulation development, device development and manufacturing process development.
Development of a lateral flow immunoassay device (IVD) at PharMacro
http://www.pharmacro.com/projects/lateral_flow_ivd
Development of a lateral flow immunoassay device (IVD). An early stage biotech company had developed a novel technology for specific detection of various strains of flu virus. This led to feasibility demonstration of a product concept based on a lateral flow immunoassay. PharMacro was brought in to advance the product development through clinical studies and submission of the 510k on a very aggressive timeline, and to manage the project.
Development of oral controlled release products at PharMacro
http://www.pharmacro.com/projects/oral_controlled_release_products
Development of oral controlled release products. A multi-national drug delivery company with expertise in oral delivery identified opportunity in controlled delivery for specific indications using the oral route. PharMacro was brought in to help generate novel product concepts, and to guide the formulation development effort. The formulations were successfully developed to meet the requirements of the target product profile. Product Designation by the Office of Combination Products (OCP) – Perils.
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