REDHAWK ENGAGES BLACK MOUNTAIN PHARMA
LAFAYETTE, LA -- June 17, 2019 -- InvestorsHub NewsWire -- RedHawk Holdings Corp. (OTC: IDNG) ("RedHawk" or the "Company") announced today that it has engaged Black Mountain Pharma Ltd. ("Black Mountain") to assist RedHawk Medical Products and Services, LLC and RedHawk Medical Products UK Ltd (collectively referred to herein as "RedHawk Medical Products"), wholly-owned subsidiaries of the Company, in the transition and ongoing maintenance of its current FDA-approved quality management system to the higher and more stringent international medical device standard, ISO 13485:2016.
Black Mountain Pharma Ltd (www.blackmountainpharma.com) was established in 2012 to provide professional Regulatory Affairs ("RA") and Quality Assurance ("QA") support for developing, implementing and sustaining quality management systems and for establishing regulatory affairs strategies for businesses associated with medical devices, pharmaceuticals, cosmetics and foods.
Led by Dr. Christopher W. Smejkal, the Black Mountain global team of professionals has a long history of developing, implementing and sustaining management systems and establishing regulatory affairs strategies for businesses associated with medical devices and pharmaceuticals. Dr. Christopher Smejkal from Black Mountain Pharma Ltd has joined RedHawk as its RA/QA consultant. He will act as the Company's Responsible Person for distribution of branded generic pharmaceuticals in the UK. Dr. Smejkal holds Bachelor of Science and Doctor of Philosophy (PhD) degrees in Biological Sciences from the University of Exeter, United Kingdom and a Master of Business Administration degree from the Open University, United Kingdom. He has extensive experience working in both the medical device and pharmaceutical industries as a senior RA/QA Professional.
ISO 13485:2016 specifies global requirements for a quality management system where an organization must demonstrate its ability, and the ability of its suppliers, to provide medical devices and related services that consistently meet customer and applicable international regulatory requirements.
As RedHawk Medical Products' business focuses on the development and sales of the Sharps and Needle Disintegration Devices (SANDD™) line of products, ISO 13485:2016 will become an integral part of RedHawk Medical Products' business culture and the way in which it operates.
ISO 13485 was specifically developed with the objective of harmonizing medical device regulatory requirements for quality management systems in major markets around the world including the United States, Europe, Canada, Japan and Australia. ISO 13485 and meets, or exceeds, all U.S. Food and Drug Administration Quality System Regulations Standard 21 CFR 820 which was established in 1978 to outline Current Good Manufacturing Practices in the United States.
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About RedHawk Holdings Corp.
RedHawk Holdings Corp., formerly Independence Energy Corp., is a diversified holding company which, through its subsidiaries, is engaged in sales and distribution of medical devices, sales of branded generic pharmaceutical drugs, commercial real estate investment and leasing, sales of point of entry full-body security systems, and specialized financial services. Through its medical products business unit, the Company sells the Sharps and Needle Destruction Device (SANDD™), WoundClot Surgical - Advanced Bleeding Control, and the Carotid Artery Digital Non-Contact Thermometer. Through our United Kingdom based subsidiary, we manufacture and market branded generic pharmaceuticals. RedHawk Energy holds the exclusive U.S. manufacturing and distribution rights for the Centri Controlled Entry System, a unique, closed cabinet, nominal dose transmission full-body x-ray scanner
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G. Darcy Klug, Chairman, CEO and CFO