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.
# # #
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
Cautionary Statement Regarding Forward-Looking
Statements
This release may contain forward-looking statements.
Forward-looking statements are all statements other than statements
of historical fact. Statements contained in this release
that are not historical facts may be deemed to be forward-looking
statements. The words "anticipate," "may," "can," "plans,"
"believes," "estimates," "expects," "projects," "targets,"
"intends," "likely," "will," "should," "to be,"
"potential" and any similar expressions are intended to identify
those assertions as forward-looking statements.
Investors are cautioned that forward-looking statements are
inherently uncertain. Actual performance and results may differ
materially from that projected or suggested herein due to
certain risks and uncertainties. In evaluating
forward-looking statements, you should consider the various factors
which may cause actual results to differ materially from any
forward-looking statements including those listed in the
"Risk Factors" section of our latest 10-K report. Further,
the Company may make changes to its business plans that could or
will affect its results. Investors are cautioned that the Company
will undertake no obligation to update any forward-looking
statements.
Media
Contact:
Julie
Calzone
(337)
235-2924
jcalzone@calzone.com
Company
Contacts:
G. Darcy
Klug, Chairman,
CEO and CFO
(337)
269-5933
darcy.klug@redhawkholdingscorp.com
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