Rochelle, Virginia (May 5, 2016) - NDA Partners Chairman Carl Peck, MD, announced today the formalization of the firm’s long-standing Expert Consultant practice in the area of medical device development and regulation. The NDA Partners medical device team offers a wide range of services to assist in all phases of the regulatory processes involved with medical devices and diagnostics, including medical equipment, implants, in vitro and imaging diagnostics, mobile and analytical software devices, and combination products. The firm’s highly experienced Expert Consultants help clients formulate effective product development strategies and implementation, determine optimal regulatory pathways, assess product readiness for regulatory submissions, plan and manage key projects, prepare and submit US and EU regulatory filings, manage regulatory affairs, and design and implement quality management and risk management systems. In addition, clients have access to top-tier Expert Consultants to assist in addressing critical issues that arise during their development programs, and in responding to and remediating regulatory agency inspection and enforcement issues.
“Our medical device team brings an extraordinary range of experience and comprehensive expertise to our clients”, said Dr. Peck. “We have grown over the past several years to become an industry leader in the area of medical device development and regulatory consulting, and have an unsurpassed ability to provide our clients with the expert guidance they need to navigate this complex area.”
The medical device practice area is led by David Feigal, Jr. MD, MPH, who joined the firm as a Partner in 2004. Dr. Feigal is a former Director of the Center for Devices and Radiological Health (CDRH), an Office Director at the Center for Drug Evaluation and Research (CDER), and Deputy Director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), and was a senior executive at Amgen and Elan Corporation, with more than 30 years of drug and device development and regulatory experience.
Members of the medical device team include:
Roberta Druyor-Sanchez, MS, former Director of Quality and Regulatory at MedApps Inc. (Alere Connect) and VP of Quality and Regulatory at Exsomed. Expert in developing novel biotechnology products, implementing ISO 13485, ISO 9001, and MDD/CE Mark Certification QMS, 510(k) submissions, and engineering systems.
Deb Koeneman, MS, former FDA Scientific Reviewer and Compliance Officer (CDRH); Director of Regulatory Affairs at Silverleaf Medical Products (Vomaris Innovations); and Senior Director of Regulatory Affairs at OrthoLogic Corporation (Capstone Therapeutics). Expert in development strategy, regulatory submissions, pre-submission meetings, and compliance.
Tim Ulatowski, MS, former Director, Office of Compliance and Senior Advisor for Enforcement, FDA Center for Devices and Radiological Health (CDRH); Director, Division of Dental, Anesthesiology, General Hospital, and Infection Control Devices (CDRH); and Director of the Investigational Device Staff. Expert in the FDA regulatory requirements for the entire life-cycle of a medical device.
Ellen Feigal, MD, Partner in NDA Partners; formerly directed the Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI); Deputy Director for Science and Vice President of Clinical Sciences, Translational Genomics Research Institute; Senior Vice President for Research and Development, California Institute for Regenerative Medicine (CIRM); and Executive Medical Director and Global Development, Amgen. Expert in companion diagnostics, “omics”, medical imaging, and protocol development.
Richard Lewis, PhD, former Deputy Director, FDA Office of Blood Regulation and Review (CBER); acting Chief of FDA Hybridoma and Hematologic Products Branch (HHPB); and regulatory reviewer, FDA Division of Hematology. Also served as a chemist for the United States Army Research Institute of Infectious Diseases. Expert in medical devices related to blood products ranging from diagnostics to medical equipment and blood components used in medical devices.
Brian Harvey, MD, PhD, former Director, FDA Division of Gastroenterology Products (CDER); Deputy Director, Office of Drug Evaluation 5; Acting Director, Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products (CDER); Associate Director, Regulatory Policy, Office of Therapeutics Research and Review; and Medical Officer (CDRH) in the Gastroenterology and Renal Branch, where he reviewed IDEs, cleared 510(k)s, approved HDEs, and worked on review teams leading to PMA approvals. Dr. Harvey also spent time in the In vitro Diagnostics group, where he was involved with the approval of the Hepatitis C PCR RNA test and various H pylori tests, and in the Cardiovascular Devices Division, as an Acting Deputy Director. Expert in Development and regulatory strategy, biologics, combination products, rare diseases, and orphan designation.
Sandy Shire, DMD, MPA, former Senior Regulatory Specialist, FDA Office of Regulatory Affairs (ORA), and Scientific Reviewer, Division of Dental, Infection Control, and General Hospital Devices (CDRH). Expert in regulatory strategy, written responses to FDA, clinical trial operations, and FDA audits, with an emphasis on Bioresearch Monitoring.
Mark Kramer, MS, former Director, FDA Office of Combination Products, and regulatory affairs executive with the medical device division of GE Healthcare. Expert in regulatory strategy, regulatory landscape assessment, FDA meeting preparation, FDA submissions, and FDA interactions for devices and combination products.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Expert Consultants at 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 approximately 60 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, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, Chief Executive Officer