Our expertise is available to you at any stage of your project, providing integrated services and flexible resource loading to accomplish your objectives.
We take tremendous pride in the caliber of our staff. Together we deliver custom solutions for each client and ensure the fulfillment of applicable regulations. We feel most fortunate to have the opportunity to work with talented professionals across the Renaissance Worldwide Solutions family and our client companies.
EXPERIENCED TEAM MEMBERS
Extensive product exposure and up-to-date technical knowledge ensures our delivery of timely, superior project results.
Our team possesses substantial industry experience, consulting for start-ups to mid-sized companies to some of the largest global medical device corporations. Partnering with clients to complement their internal resources, we work closely with client design and development teams to support their efforts. We bring more than 50 years of combined clinical and regulatory expertise to every project.
Allison A. Sakara, RN, MSN, PNP/FNP, PHRN
Allison A. Sakara is President and Managing Member of Renaissance Worldwide Solutions, LLC, a woman-owned management firm. Allison’s over 30 years of medical regulatory consulting experience serves clients worldwide through RWS’s subsidiary Medical & Regulatory Affairs Specialists, LLC. As a Managing Member of Natural Air E-Controls, LLC, Allison brings her regulatory affairs expertise to HVAC control manufacturing and indoor air quality medical device manufacturing.
One of the nation’s foremost experts in the practice of disaster nursing and disaster healthcare, Allison has dedicated her life to serving those in need in their most desperate hour. In 2005, she was recognized as a Distinguished Member of the Year by the National Disaster Medical System, In addition to direct disaster response roles, she provides expertise on Disaster and Pandemic preparedness for hospital committees, businesses, and educational organizations as the Executive Director of the High Alert Institute, Inc. a 501c3 Not-for-Profit.
Allison’s clinical experience as a nurse and nurse practitioner includes work in pediatrics, hematology, oncology, critical care transport, and disaster response. If there is a tough job in nursing or healthcare that no one else wants, Allison has mastered it. Allison continues to provide medical care and psychological support as both a nurse practitioner and a therapy dog handler. She was also a Technical Advisor for Paramount Television.
Mona Kelley, RN, MSN
Mona Kelley is a Managing Member of Renaissance Worldwide Solutions, LLC. Beginning as a Senior Research Associate for Medical & Regulatory Affairs Specialists, LLC, she quickly rose to full partnership in the parent company (RWS). Mona is an expert in the fields of emergency nursing, trauma care, and disaster response. Combining these scientific strengths with many years of national leadership and mentoring, this graduate of Excelsior and Concordia Universities brings a robust skillset to the RWS team.
Workplace Safety and Health Education are Mona’s passions. She has served on the Emergency Nurses Association (ENA) Foundation Board of Trustees, as President of the Tennessee ENA, and continues to serve as a state and chapter officer. Throughout her tenure, Mona has advocated for the safety of healthcare providers. Today she continues these efforts, working with legislators and healthcare stakeholders to improve safe care environments and practices. Mona also encourages and supports the educational advancement of healthcare workers through the ENA, as well as her collegiate teaching.
Maurice A. Ramirez D.O., Ph.D.
BCDM, BCEM, BCFM, BCNMM, BCSM, BCGM, CNS, CMRO
Dr. Maurice A. Ramirez is a former Senior Physician/Federal Medical Officer, Emergency Room Doctor, Disaster Medicine Specialist and Bio-terrorism/Hazmat expert with clinical and field response experience spanning over 2 decades. He has published numerous articles in professional and scientific journals and has been cited in over 24 textbooks. Dr. Ramirez is author of The Complete Idiot’s Guide to Disaster Preparedness (Alpha Books, 2009) and Making Sense of Disaster Medicine (Oxford Univ. Press, 2010).
He was the Technical Advisor for Spike TV’s: Surviving Disaster and 1000 Ways to Die. Suffering from a rare, progressive, acquired orphan illness since 2009, the symptoms ultimately resulted in Total Permanent Disability necessitating Indefinite Medical Leave from Federal/State service, clinical practice, public speaking and consulting beginning June 29, 2012.
In 2017, Dr. Ramirez was the first person to receive the Lifetime Achievement Award in Disaster Medicine for his contributions to healthcare security and disaster medical response worldwide. Dr. Ramirez serves as Emeritus Medical Director of the High Alert Institute.