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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 are fortunate to have the opportunity to work with talented professionals within Medical & Regulatory Affairs Specialists and our client companies.


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 and 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

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.

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.