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USFDA Pharmaceutical, Medical Device
and Biologics Regulatory Consulting




Combining over 100 years of FDA and Industry experience, IHL Consulting Group, Inc. is comprised of FDA consultants committed to providing a full range of consulting services in the areas of pharmaceutical, medical device, and biologics regulatory compliance. From the early stages of development to commercial production, our consultants have serviced small start-up clients as well as multi-national Fortune 500 companies. Our goal is to provide you with courteous, expedient, pragmatic and professional advice of the highest caliber - whether it is a small assignment or a comprehensive compliance solution. With former FDA Field Investigators and industry experts on staff, we offer a unique and blended perspective from the regulatory and industry environments.

IHL Consulting Group, Inc. has also formed strategic alliances with other regulatory service professionals/partners when your needs call for specialized attention.


Robert L. Lewis, President:    Robert has been a consultant to US FDA regulated industries since September 2000 when he founded IHL Consulting Group, Inc. During his ten years with the US Food and Drug Administration, Robert served as an Investigator / Drug/Pharmaceutical Specialist, Robert conducted numerous cGMP and NDA / ANDA pre- Approval inspections at major domestic and international pharmaceutical facilities. He was also Co-Leader of Atlanta District Drug Team, and the Assistant ANDA / NDA Pre- Approval Program Manager. Robert now provides regulatory advice to a diverse array of clients, including specialized consultation at the Executive and Leadership level. Robert has been a frequent speaker at industry conferences and currently oversees all IHL consulting operations. He holds a Bachelor of Science Degree in Applied Biology from Georgia Tech.

Robert C. (Bob) Coleman, Senior Compliance Expert, Pharmaceuticals:    Bob recently retired after 35 years with FDA, the last 13 of which he was the National Drug Expert Investigator. As a Drug Specialist and the National Drug Expert, Bob conducted literally hundreds of cGMP and Pre-Approval drug inspections both domestically and inter- nationally, specializing in sterile dosage forms and aseptic processing. He has been one of the principal instructors in fundamental FDA drug training courses for Investigators and was instrumental in the FDA Drug Certification program, serving as Board Member for both the Level II and Level III/Pharmaceutical Inspectorate Boards. Bob has also received special recognition at the highest levels including the Commissioner’s Special Citation and Outstanding Service Awards.

Karen A. Coleman, Senior Compliance Expert, Medical Devices: Karen retired after 30 years with FDA, the last 15 of which she was the National Device Expert Investigator. As a Device Specialist and as the National Device Expert, Karen has conducted key cGMP and Pre-Market inspections involving the most complex devices and diagnostic equipment, including sterile devices [e.g. angioplasty devices, stents, heart valves, pacemakers, dialysis filters, urinary catheters and other latex products; blood filters, contacts, and surgical equipment], tissue devices, and radiological equipment. She has served as a principal FDA instructor in fundamental agency device training courses and was an instrumental FDA representative on the Global Harmonization Task Force {GHTF - Study Group 4 (Auditing)} which included work on major GHTF guidance documents for Regulatory Auditing, Audit Strategy, and Regulatory Audit Reports. Karen has also received special agency recognition at the highest levels including the Commissioner’s Special Citations, Commendable Service Awards, and Outstanding Service Awards.


FDA Pharmaceutical, Medical Device and Biologics Regulatory Consulting






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