MEDICAL & REGULATORY AFFAIRS SPECIALISTS, LLC
FROM DE NOVO TO LEGACY
Safe and effective products are the true endpoints of research and development. Medical & Regulatory Affairs Specialists provides project consultation for select corporate partners and clients. We have assisted our clients in achieving tremendous success in securing global regulatory approvals for de novo and legacy technologies. We support you on the continuum of your regulatory pathway, from submission to maintenance of post-market compliance.
YOUR VISION, YOUR TEAM, OUR SUPPORT
SYSTEMATIC SCIENTIFIC LITERATURE REVIEWS
FAILURE MODE & ADVERSE EVENT DATABASE ADJUDICATION
DATA MINING & ANALYSIS
PREPARATION OF STATISTICAL ANALYSIS
Allison A. Sakara, RN, MSN, NP, PHRN
Primarily serving the endovascular medical device industry, Allison has worked as a clinical and regulatory consultant for nearly 30 years. She co-founded this woman-owned firm in 2011, bringing decades of clinical and research experience in the fields of pediatrics, hematology/oncology, and disaster response. Allison also has shared her expertise with hospital committees, disaster responders, public health and policy groups, not-for-profit organizations, and educational institutions. Pet therapy, animal rescue, and green energy programs are her off-duty passions.