Halloran Consulting Group Hires Former FDA Branch Chief

Halloran Consulting Group Inc. has hired former U.S. Food and Drug Administration (FDA) branch chief Sonna Patel-Raman, Ph.D. Halloran is a management consulting company for the life science industry that addresses the obstacles associated with the rising costs of healthcare, drug, and medical device development.

“Halloran’s work in the device regulatory space has grown tremendously since our founding, principally because of the rapidly changing regulatory environment,” said Laurie Halloran, president and CEO. “Sonna’s arrival at Halloran signifies the next stage in Halloran’s growth, and an added depth and dimension to the expertise and guidance we offer clients.”

Prior to joining Halloran, Patel-Raman was a branch chief and senior reviewer for more than seven years in the Center for Devices and Radiological Health at the FDA. She worked in the Division of Cardiovascular Devices in the branches of Circulatory Support/Structural Heart Devices. Patel-Raman managed a staff of reviewers and clinicians in the pre-market review of regulatory submissions—pre-market approval applications, humanitarian device exemptions, investigational device exemptions, 510(k)s, etc.—and provided leadership on various issues related to bench testing, clinical trials (informed consent, design, conduct, and analysis), post-market studies, and compliance. She gained extensive experience in the review of investigational device exemptions and pre-market approvals, and preparation for FDA advisory panel meetings.

Patel-Raman’s hiring reflects a larger pattern of growth for the consulting group. Since the second quarter of 2013, Halloran reports growing more than 40 percent, and company officials expect the rate of expansion to continue through this year and into 2015.

Based in Waltham, Mass., Halloran is a specialty consulting firm that partners with life-science companies to optimize their
development. Halloran works with industry organizations of all types, including biotech, pharma, medical device, and service providers to identify gaps and implement solutions, helping companies achieve excellence in regulatory, quality, and clinical development.