Ms. Bronich-Hall’s experience with quality management systems, conducting quality control and supplier audits, and leading inspections conducted by FDA will be beneficial to our medical device clients. We are delighted that she has joined the NDA Partners team.
ROCHELLE, Va. (PRWEB) September 12, 2018
NDA Partners Chairman Carl Peck, MD, announced today that Lauren Bronich-Hall, a quality management professional and former Senior Director of Regulatory Affairs and Quality Systems at WellDoc, Inc., has joined the firm as an Expert Consultant.
As Senior Director of Regulatory Affairs and Quality Systems at WellDoc, Inc., she conducted quality control and supplier audits, led inspections conducted by FDA, and successfully submitted and received clearance for two 510(k) applications for class II medical devices. Ms. Bronich-Hall has served in multiple capacities within the emerging industry of digital health, in addition to initiating and refining procedures to meet the needs of an evolving organization.
Prior to joining NDA Partners, Ms. Bronich-Hall served as Director of Patient and Provider Education at PRIME Education, LLC, where she provided strategic direction in business development and program execution for independent medical education and quality improvement projects.
“Ms. Bronich-Hall’s experience with quality management systems, conducting quality control and supplier audits, and leading inspections conducted by FDA will be beneficial to our medical device clients,” said Dr. Peck. “We are delighted that she has joined the NDA Partners team.”
Ms. Bronich-Hall earned her Bachelor of Science degree in Dietetics from James Madison University in Harrisonburg, Virginia and a Master of Science degree in Health Sciences Administration from Towson University in Maryland. She is a registered and licensed dietitian, as well as a Certified Diabetes Educator, and has led various initiatives to improve patient outcomes in settings including Johns Hopkins Bayview Medical Center.
About NDA Partners
NDA Partners is a life sciences management consulting firm focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and management of client product development programs.
Earle Martin, Chief Executive Officer