Author: Julie Kaloides

CSafe Global has received approval from the Federal Aviation Administration (FAA) for their new RAP ULD container, the latest addition to the company’s full line of active and passive cold chain packaging solutions.
CSafe Global’s commitment to addressing its customers’ needs has been proven yet again with the announcement of the FAA approval of the new CSafe RAP. CSafe has recognized the increasing needs of pharmaceutical and life-science companies to ship large quantities of temperature-sensitive products to patients around the world.
The CSafe RAP is the latest innovation in high performing temperature controlled containers (TCC) purposely designed to support life-science companies with air cargo transportation of life-enhancing or life-saving products.
Developed and designed with performance in mind, the CSafe RAP utilizes innovative heating and compressor-driven cooling technologies together with advanced ThermoCor® VIP insulation to eliminate the payload risks associated with extreme ambient temperature conditions and long-duration shipments. The new CSafe RAP active container system leverages the proven performance and capabilities of the well-established CSafe RKN to remove the operational and environmental challenges encountered with global temperature controlled shipments.
With its newly designed composite exterior panels, the CSafe RAP is not only durable, but is also voluminous, and can easily accommodate up to four standard US-pallets or five standard Euro-pallets. It is approved for use on both lower and upper decks of aircraft, thus allowing expansion of lanes and flights available to pharma companies for delivery of high-value biopharmaceutical products. The CSafe RAP provides an extended battery run time of more than 100 hours, a large payload volume of 6.68m3, and unmatched operational capabilities, maintaining constant payload temperatures even at extreme ambient temperatures from -30°C to +54°C.
Brian Kohr, President and CEO of CSafe Global, remarks, “FAA approval of our new active system is a very important milestone for CSafe Global and puts us another step closer to our planned launch date of early 2018 for the CSafe RAP. By upgrading to CSafe’s active RAP solution, shippers will benefit from the industry’s best performing temperature controlled container to transport their large shipments of valuable product effectively and successfully, time after time, with utmost confidence.”
CSafe Global will continue to provide pertinent information about the forthcoming launch of the new CSafe RAP, including announcements about airline approvals and updates to the global service network. Furthermore, the operational qualification (OQ) report for the new CSafe RAP is now finalized, with this data being available to pharma shippers for system qualification purposes. Pharmaceutical companies may contact CSafe Global at sales@CSafeGlobal.com or their local CSafe sales representative for a copy of the OQ report.

CSafe Global’s Service Center in Puerto Rico continues to stay 100% operational, and ready to support our valuable customers and partners.
Since CSafe Global was founded with the objective to help prevent patient suffering resulting from the spoilage or delay of crucial medicines, we understood that remaining closed after Hurricane Maria was just not an option for us. We needed to be ready and prepared to support our pharma customers, and to address their crucial needs for temperature-controlled shipping solutions.
Meet our dedicated team members in the SJU Service Center who, in coordination with the CSafe Global Operations team, arranged for generators to be available to ensure power at our local service center, provided satellite phones and internet hotspots to maintain communication with our customers, installed tanks for drinking water, and provided housing and transportation services for our local employees to ensure operational readiness. As a result, CSafe Global was able to fully restore our operations in Puerto Rico within 72 hours of the devastating hurricane. Since then, CSafe Global has been regularly chartering our CSafe RKN active containers onto the island to ensure system availability.
CSafe Global continues to stand ready to support our customers with their temperature-sensitive cargo needs and the cold-chain transportation of their life-saving medicines off the island, and to their patients around the world.

NASHVILLE, Tenn., (BUSINESS WIRE)
Clearwater Compliance, a top-ranked, award-winning provider of healthcare cyber risk management and compliance solutions, has been named one of the country’s fastest growing consulting firms by Consulting magazine. It was recognized as the 32nd fastest growing firm of 75 firms qualified for the ranking. Growth for Clearwater in total revenue between 2013 and 2016 was 170 percent. Consulting magazine’s Fastest Growing Firms list recognizes the profession’s top movers and shakers in terms of revenue growth.
Solutions that are exclusively endorsed by the American Hospital Association, Clearwater has worked with hospitals and health systems, including more than 40 of the top Integrated Delivery Networks in the country, Fortune 100 organizations, and federal government institutions.
Consulting firms of all sizes and sectors are ranked by rate of revenue growth between 2013 and 2016. In all, 75 firms qualified for the ranking, which requires a minimum growth rate of 20 percent to be eligible.
“We are very proud to be recognized by Consulting magazine as one of the fastest growing consulting firms in the U.S.,” said Bob Chaput, CEO of Clearwater Compliance. “Clearwater has experienced unprecedented growth with double-digit new client wins, expanded contracts, and double the number of employees over a three-year period. The past two years have seen an exponential escalation in cyber attacks on the healthcare industry. Progressive leaders are connecting the dots between cyber risk and patient harm, and we applaud them for their visionary leadership.”
“With mind-numbing growth, there’s absolutely no doubt these 75 consulting firms are disrupting the industry from the bottom up — they are the profession’s Fastest Growing Firms for 2017,” said Joseph Kornik, publisher and editor-in-chief of Consulting magazine.
The company was included in the 2017 Inc. 5000 list of America’s Fastest Growing Private Companies. New endorsements by state hospital associations have added more than 300 hospitals in Georgia, Montana, and Arkansas. New partnerships include Intel and selection for membership in the NIST National Cybersecurity Excellence Partnership.
The Fastest Growing Firms will be featured on www.consultingmag.com and will be available in the November issue of Consulting magazine on November 10.
About Clearwater Compliance
Clearwater Compliance, LLC is a leading provider of hospital and health system compliance and cyber risk management solutions. Its mission is to empower hospitals and health systems to successfully manage healthcare’s evolving cybersecurity risks and ensure patient safety. Exclusively endorsed by the American Hospital Association, Clearwater solutions have been deployed within hundreds of hospitals and health systems, Fortune 100 organizations and federal government institutions. More information about Clearwater Compliance is at www.clearwatercompliance.com.
About Consulting magazine
Consulting® magazine is the flagship publication of the consulting profession featuring the latest information on consulting careers, thought leadership and corporate strategies. In addition to providing industry insights, Consulting® hosts award dinners as part of its Achievement Awards series—honoring Women Leaders in Consulting, The Top 25 Consultants, The Rising Stars of the Profession, The Best Firms to Work For, and Social & Community Investment.
Contacts
Clearwater Compliance, LLC
Kelly Motley, 615-483-0365
Kelly.Motley@clearwatercompliance.com

BALTIMORE, Nov. 2, 2017 /PRNewswire/
In honor of National Sleep Comfort Month in November, Senior Helpers®, the nation’s premier provider of in-home senior care, is offering sleep tips to promote the importance of healthy sleep habits for seniors. According to a recent survey of 1,000 senior citizens ages 65+ issued by the brand, nearly 70 percent of seniors do not meet the National Sleep Foundation’s sleep duration recommendation of 7-8 hours per night for older adults. The study also finds a large majority of seniors experience sleep fragmentation, with 88 percent waking up at least once per night, and nearly 30 percent waking up three times or more. Without sufficient sleep, seniors may experience a reduced quality of life including depression, difficulty concentrating, excessive sleepiness and increased risk for accidents and illness.1
“Sleep is vital to physical, mental and emotional well-being no matter what your age; however, it’s not uncommon that as people grow older, many find themselves sleeping less and having more trouble falling and staying asleep at night2,” said Peter Ross, CEO and co-founder of Senior Helpers. “Getting consistent, quality sleep every night can help with immune health, depression, cognitive issues and a number of other health complications that tend to impact seniors. If you are experiencing difficulties with sleep, it is important to seek help and take measures to get the quality rest you need in order to live the happy and healthy life you deserve.”
In an effort to help seniors sleep more soundly this month and beyond, Senior Helpers offers the following sleep tips:
Exercise during the day
Physical activity is recommended to improve both sleep quality and overall sleep duration.1 Try incorporating moderate aerobic exercise into your daily routine like swimming, fast walking or even ballroom dancing, but be sure to consult with your doctor before jumping into any new exercise regimens.
Implement a pre-bed time ritual
Calming nighttime activities will help your body relax and slow down, making you better prepared for bed. Only one-third of seniors are able to fall asleep instantly, and activities such as listening to music, taking a warm bath and meditation are found helpful in expediting the unwinding process.2
Avoid afternoon naps
Sleeping in the day can make it more difficult to fall and stay asleep at night. The good news? More than half (55 percent) of seniors don’t find themselves needing to nap more as they age.2 If you do find yourself needing some mid-day shut eye, limit naptime to 30 minutes or less.
Drink fewer fluids at night
Bathroom breaks are the most common sleep disruptor among older adults.2 Avoiding liquids a couple of hours before bedtime will limit how often you wake up to use the bathroom throughout the night.
Minimize technology use before bed
Too much light from video screens at bedtime can affect the production of melatonin, giving your body the impression you aren’t ready for sleep3. The best advice is to stop watching TV or using smartphones and other screen devices at least 30 minutes before bedtime to give your brain a rest and the correct signal that it is time for sleep.
Founded in 2001 with a vision to help seniors who wish to remain in their homes despite age-related illnesses and mobility challenges, Senior Helpers serves elderly individuals and their families around the world. Senior Helpers differentiates itself with its proprietary, specialized programs that have been developed in collaboration with leading medical experts. The company was the first provider in the industry to offer specialized care services for individuals with Alzheimer’s and dementia through its Senior GEMS® program. Senior Helpers added a new Parkinson’s Care Program in 2016, a specialized training program for caregivers created in conjunction with leading experts from the National Parkinson Foundation’s Center of Excellence.
For more information about the company, visit www.seniorhelpers.com. To learn more about franchising opportunities, visit www.seniorhelpersfranchise.com.
About Senior Helpers
Senior Helpers is a premier in-home senior care provider in the U.S. with 311 franchised businesses operating across the globe. Founded in 2001 with a vision to help seniors who wish to remain in their homes despite age-related illnesses and mobility challenges, Senior Helpers has now cared for tens of thousands of seniors with a pledge to provide “care and comfort at a moment’s notice.” Senior Helpers offers a wide range of personal care and companion services, including trained Alzheimer’s, dementia and Parkinson’s care, to assist seniors who wish to live independently. Learn more by visiting www.seniorhelpers.com.
1 National Sleep Foundation
2 Based on a 1,000 person survey of seniors ages 65+ conducted by Senior Helpers, Sept. 2017
3 https://sleep.org/articles/ways-technology-affects-sleep/
Contact:
Lindsay Anthony
Havas Formula
(619) 234-0345
seniorhelpers@havasformula.com

Farmville, NC. October 30, 2017
CMP Pharma today announced that CaroSpir® (Spironolactone Oral Suspension, 25 mg/5 mL), the first and only FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone, is now available. CaroSpir was approved by the FDA on August 4, 2017 and is now available through normal retail distribution.
CaroSpir oral suspension ensures that adult patients who have difficulty swallowing, or who cannot swallow tablets, receive a stable and consistent dose of spironolactone every time. Until now, patients who have required a liquid form of spironolactone have had to rely on unapproved pharmacy compounded formulations, which typically have limited shelf life, are not quality control tested for potency and sterility/bioburden, and are typically not reimbursed by insurance companies.
With FDA approved CaroSpir, the challenges around short-term shelf life and lack of quality control of compounded spironolactone liquids are addressed. CaroSpir is available in 118mL and 473 mL bottles, both of which have 24-month dating and are manufactured and tested at CMP Pharma’s FDA inspected GMP manufacturing facility in North Carolina. CaroSpir comes in banana flavor to improve compliance. It does not have a black box warning, nor does it have any special handling or storage requirements.
“CaroSpir is intended for a subset of the patient population that needs spironolactone, but has difficulty swallowing or inability to swallow. Until today there was no FDA-approved oral suspension of spironolactone to satisfy this unmet need. The availability of CaroSpir now gives healthcare providers and appropriate patients a convenient, safe and approved liquid option,” said Gerald Sakowski, CEO of CMP Pharma, Inc.
CaroSpir oral suspension is now available. For more information, contact CMP Pharma at 252-753-7111 or visit CaroSpir.com.
About CaroSpir®
CaroSpir® (spironolactone oral suspension) is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema and to reduce the need for hospitalization for heart failure, and is usually administered in conjunction with other therapies. CaroSpir® is also indicated for use as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents, as part of comprehensive cardiovascular risk management. Lastly, CaroSpir® is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.
CaroSpir® is contraindicated for patients with the following conditions: hyperkalemia, Addison’s disease, and concomitant use of eplerenone.
About CMP Pharma, Inc.
CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value pharmaceutical products, including liquids and semi-solids. CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients.
Additional Important Safety Information:

CONTRAINDICATIONS
CAROSPIR is contraindicated for patients with the following conditions:
Hyperkalemia
Addison’s disease
Concomitant use of eplerenone
WARNINGS AND PRECAUTIONS/ADVERSE REACTIONS
CAROSPIR may cause the following conditions. The following clinically significant adverse reactions were reported with CAROSPIR:
Hyperkalemia
Hypotension and Worsening Renal Function
Electrolyte and Metabolic Abnormalities
Gynecomastia
Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites
The most common adverse reaction (incidence > 5%) with CAROSPIR treatment is the increased occurrence of gynecomastia in men.

Altaris Capital Partners, LLC (“Altaris”) announces an investment in G&H Orthodontics.
G&H Orthodontics is a global designer, manufacturer and distributor of clinical orthodontia products. Headquartered in Franklin, IN, G&H sells a full suite of American-made orthodontic brackets, bands, tubes, wires, springs, elastomerics and other dental consumables to customers in more than 90 countries. www.ghorthodontics.com
Altaris was advised on this transaction by Schiff Hardin LLP.

Minnetronix, maintaining our perfect record, has now undergone seven successful FDA Quality System Inspection Technique (QSIT) inspections with No Action Indicated (2017, 2016, 2015, 2010, 2008, 2004 and 2001). We achieved this milestone by continually assessing and improving our Quality Management System (QMS). In a typical year, our system is subjected to more than 30 audits by regulators and customers in addition to our own internal audits. We use the audits as a tool to help identify weaknesses and improvement opportunities, which further enhances and strengthens our processes and systems.
Our state-of-the-industry QMS encompasses design, development, manufacturing, commercialization, and service of medical electronic and electromechanical products. The Minnetronix QMS is a true Original Equipment Manufacturer (OEM) medical device QMS and meets all of the requirements of the medical device regulations. Our QMS is based on continually improving our development, manufacturing, and business processes. Our structured and agile quality system allows us to tailor our services to meet individual program needs and to achieve the best outcomes for your business.
Our continued perfect record with FDA inspections underscores Minnetronix’ commitment to quality as we create new technologies and therapies that solve unmet clinical and business needs for patients and medical device companies.

Quick and efficient disaster response and emergency management can be ensured through the use of thermally insulated boxes and actively powered shipping containers which protect temperature critical medical supplies due to extended hold times during catastrophic conditions.
CSafe Global, the world’s leading expert in cold chain solutions, producing actively controlled mobile refrigeration units for life sciences, healthcare, military and international disaster relief agencies, is now assisting Hurricane Harvey aid organizations and medical facilities working in Southeast Texas by offering the use of their mobile battery powered temperature controlled containers for transporting and storing blood, vaccines and other temperature sensitive healthcare supplies. CSafe Global also stands ready to support disaster relief organizations if necessary should Hurricane Irma intensify and become more than a potential threat.
Products available to disaster-responding agencies include passive insulated shipping boxes, active mobile containers (such as the company’s AcuTemp® AX56L mobile refrigerator/freezer which can be powered by AC or battery) and the CSafe® RKN refrigerated pallet sized air cargo container. These packaging solutions thrive on thermal integrity and proficient operation which results in secure shipment and delivery to those in need, boosting the resiliency of disaster-stricken areas.
For more information, relief agencies and medical facilities working in the areas affected by the hurricane can contact CSafe directly at +1 937-245-6393 or via disasterrelief@csafeglobal.com.
About CSafe Global
CSafe Global manufactures AcuTemp® and Kalibox brands of passive packaging and hand-held mobile carriers, the CSafe® brand of active containers, and is the exclusive manufacturer and provider of ThermoCor® vacuum insulation. The active solution product assortment includes the industry leading CSafe RKN, which utilizes heating and compressor-driven cooling technology to eliminate the risks associated with extreme ambient conditions as well as the conditioning, cost, aggravation and environmental challenges associated with dry ice and PCM’s. CSafe Global’s AcuTemp brand has provided temperature management solutions since its founding more than 25 years ago. The courier is a simple-to-use, reusable temperature management system with multiple sizes, temperature ranges and durations designed to protect vital shipments during last mile delivery. The passive packaging assortment includes solutions for 2-8°C, CRT and frozen shipments with temperature hold times up to 240 hours.

CMP Pharma announced that the US Food and Drug Administration (FDA) has granted final approval of the company’s New Drug Application (NDA) for CaroSpir® (Spironolactone Oral Suspension, 25 mg/5mL), the first and only FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone.
“CaroSpir® provides a stable, ready to use and consistent liquid treatment option for adult patients, including those who have difficulty swallowing, or who cannot swallow tablets,” said Gerald Sakowski, CEO at CMP Pharma, Inc. “Up until now, these patients have been prescribed a pharmacy compounded liquid form of spironolactone. The dosing inconsistencies of compounded liquids have long been a persistent challenge for physicians.”
CaroSpir® will be introduced early in the fourth quarter of 2017. For more information, contact CMP Pharma at 252-753-7111, or visit CaroSpir.com
About CaroSpir®
CaroSpir® (spironolactone oral suspension) is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema and to reduce the need for hospitalization for heart failure, and is usually administered in conjunction with other therapies. CaroSpir® is also indicated for use as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents, and as part of comprehensive cardiovascular risk management. Lastly, CaroSpir® is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.
CaroSpir® is contraindicated for patients with the following conditions: hyperkalemia, Addison’s disease, and concomitant use of eplerenone.
About CMP Pharma, Inc.
CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value liquid and semi-solid pharmaceutical products. CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients.
Additional Important Safety Information
Contraindications
CAROSPIR is contraindicated for patients with the following conditions:
Hyperkalemia
Addison’s disease
Concomitant use of eplerenone
Warnings and Precautions / Adverse Reactions
CAROSPIR may cause the following conditions.
Hyperkalemia
Hypotension and Worsening Renal Function
Electrolyte and Metabolic Abnormalities
Gynecomastia
Impaired neurological function/coma in patients with hepatic impairment, cirrhosis and ascites
The most common adverse reaction (incidence > 5%) with CAROSPIR treatment is the increased occurrence of gynecomastia in men.