LOS ANGELES, Aug. 21, 2017 /PRNewswire/ -- Global Health Solutions, LLC ("Global Health Solutions"), a Georgia based biotechnology company developing next-generation therapies for wound care, infection control, and dermatologic indications, announced today that it has entered into a service agreement with Camargo Pharmaceutical Services, LLC ("Camargo"). Camargo will be providing regulatory consulting services for Global Health Solutions' topical onychomycosis candidate, which is built upon its proprietary PermaFusion™ delivery technology. The program will concentrate on obtaining new drug approval from the Food and Drug Administration for this novel topical formula.
Camargo is the most experienced global strategist specializing in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act and similar global processes. Over the last decade, Camargo has established an unrivaled track record with 505(b)(2) IND and NDA preparations and submissions, including participation in more than 1100 Agency meetings and more than 200 FDA NDA and ANDA approvals.
Global Health Solutions' founder and CEO, Bradley Burnam, states: "Approximately 10% of the world population suffers from onychomycosis. Current topical therapies provide little relief, leading the majority of patients to seek potentially toxic, oral options. We are confident that our candidate onychomycosis formula will provide a safe, superior alternative to current topical and oral treatment modalities." Echoing this statement, Global Health Solutions' Chief Medical Officer, Neil Ghodadra, MD, states: "As a practicing physician, I am acutely aware of the ineffectiveness of currently available, topical onychomycosis products. Initial proof of concept trials have shown dramatic effectiveness of our candidate, rivaling even the best oral options. We are excited to partner with Camargo and commence full-scale clinical trials on this revolutionary topical, which we believe will become the standard of care for the treatment of onychomycosis."
"In bringing Camargo's 505(b)(2) drug development expertise together with Global Health Solutions' delivery technology, our partnership will help to achieve our client's goals," says Camargo CEO, Ken Phelps. "We look forward to working with Global Health Solutions to create value and develop their product in the most time- and cost-effective manner."
About Global Health Solutions, LLC
Global Health Solutions, LLC, is a concept to approval research, development, and commercialization entity focused on novel, best in class products for infection control, skin, and wound care. The company's proprietary technologies are used every day by world-leading healthcare institutions to care for a variety of skin and wound conditions. For more information, visit www.globalhealthrx.com.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com
The statements contained herein may include prospects, statements of future expectations, and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance, or events may differ materially from those expressed or implied in such forward-looking statements.
SOURCE Global Health Solutions