Renaissance Worldwide Solutions, LLC
Renaissance Worldwide Solutions (RWS) is a small, rural, women-owned and nurse operated, international consulting firm. Located in the Tiger Creek Nature Conservancy, a rural central Florida conservation and wildlife preserve that is home to the second most diverse ecosystem on the planet, this limited liability corporation is the management company for several healthcare and global health entities including:
• Medical & Regulatory Affairs Specialists, LLC (MRAS)
• Aeolian Wind Technologies, LLC (AWT)
• Failure Event Database Search Engine (FEDS Engine)
• High Alert Institute, Inc. (HAI)
In addition to being the parent company to MRAS and AWT, RWS is the financial backbone of High Alert Institute since its inception in 2011. High Alert Institute is a 501(c)3 dedicated to the education of healthcare workers and community volunteers in Disaster Preparedness and Response.
Originally founded by Dr. Maurice A. Ramirez, D.O., Ph.D. in the weeks after the 2001 9/11 attacks to provide disaster preparedness, mitigation, response and recovery education for businesses and healthcare, the company was registered in 2004 as High Alert, LLC.
A professional speaker since 1984, Dr. Ramirez established his emergency medicine practice in 1992 and by 2009, High Alert, LLC managed all three operations.
Coincidentally, in 1992 while working as a nurse practitioner for Yale University School of Medicine, Allison A. Sakara, RN, MSN, CRNP began overseeing clinical trials and telemedicine network development for the Pediatric Hematology and Oncology Department. Part-time consulting in biologics and informatics was a natural outgrowth of this experience and over the next ten years, the range of services grew along with a solid reputation for quality work. Initially these services were known only by the founder’s name, then by Healthcare Consulting Services after moving to Pittsburgh, PA.
In 2009, Healthcare Consulting Services and High Alert began working together expanding the scope of clientele for both companies. In 2010, prior to the Haiti earthquake, the two companies merged to form Renaissance Worldwide Solutions, LLC. As part of that merger, Healthcare Consulting Services was rebranded as Medical & Regulatory Affairs Specialists, LLC, while High Alert was rebranded as High Alert International, LLC to reflect its worldwide range of clients. In 2011, Dr. Ramirez was forced to retire from RWS for health reasons, effectively closing the professional speaking and publishing operations. RWS opted to convert the remaining publishing mark and the disaster education business to a 501(c)3 not-for-profit, the High Alert Institute, Inc. The medical practice of Dr. Ramirez continued to be managed by RWS, until declining health forced his full retirement in June 2012. During these two years, full ownership of the corporations transitioned to Ms. Sakara and plans to relocate herself and the businesses to their current location in Lake Wales, Florida were completed. Since Allison Sakara assumed the reigns at RWS, MRAS not only accepted new clients on a referral basis but also expanded service lines to include comprehensive literature review, government database review, and specialty regulatory affairs services.
Today, MRAS provides clinical and regulatory affairs support for the medical device industry worldwide. MRAS serves the full spectrum of medical device companies from large multinational device manufacturers to start-up companies but the majority of clients are small businesses.
In December 2012, the principle and owner of RWS, Allison Sakara embarked on a renewable energy project at the Lake Wales, FL property. Over the ensuing 23 months, wind and solar solutions were investigated. In December of 2014, the principle installed an 81 panel, 21.5kW Tier 2 solar PV system on the residential portion of the property. While the principle of RWS developed and deployed the privately funded residential solar project, regulatory hurdles hampered deployment of the planned wind turbine. With the determination by Duke Energy that the property required a commercial power meter and utility enclosure, RWS assumed the management and development of the 4800 Ben Hill Trail Wind Turbine project. This would ultimately lead to the development of wind energy tower noise mitigation system and the formation of Aeolian Wind Technologies, LLC.
With the expansion of safety reporting requirements worldwide and searchable government adverse event databases, RWS undertook to develop adverse event database search software. With decades of experience in both engineering and computer programming with Mr. Michael Bivins and Florida IS Consulting was the ideal joint venture partner to assist RWS in development of the government database search software. The beta test of this search tool has allowed MRAS to accept twice the clients since 2015 as could be serviced in 2014. The Failure Event Database Search Engine is in final phases of beta testing and will be available soon.