Specializing in FDA Regulatory Matters

Professional Staff

Senior Executive Staff

Edward Steele
Chairman and Chief Executive Officer (CEO)

Edward Steele is the founding partner of EAS Consulting Group, LLC. He serves as the Chairman and Chief Executive Officer where he provides overall policy direction for the company. He formed EAS as an independent company through acquisition in 2006. Mr. Steele had a distinguished 30 year career at FDA, beginning as a chemist in the New York District and later holding increasingly responsible positions at the Center for Food Safety and Applied Nutrition in Washington, D.C. Upon his retirement from FDA, he served as the vice president of AAC Consulting Group and Kendle International.

Dean Cirotta
President and Chief Operating Officer (COO)

EAS President and Chief Operating Officer Dean Cirotta has 25 years of experience in pharmaceuticals firms, including senior management roles with responsibility for regulatory affairs, compliance, quality assurance and overall corporate management. Immediately prior to joining EAS, he was president and COO of UPM Pharmaceuticals in Baltimore, MD. Prior to UPM he was president and COO of Leitner Pharmaceuticals. Previously, he was vice president of global regulatory affairs for the pharmaceutical division of Bausch & Lomb.

Bryan J. Coleman
Senior Director Pharmaceutical & Device Consulting Services

Bryan Coleman has 24 years of experience in FDA Investigations, OTC pharmaceuticals and tobacco quality and compliance, including various management roles with responsibility for regulatory compliance, quality assurance and multi-site audits and FDA inspections management. Immediately prior to joining EAS, he was Senior Manager of Quality Programs and Projects at Altria Client Services in Richmond, VA. Prior to Altria he spent nearly 14 years as the Director of Quality and Compliance for Research and Development at Pfizer Consumer Healthcare. Bryan’s five years of FDA experience began as a chemist in the Buffalo District and later as a consumer safety officer (CSO/Investigator) with Baltimore District where he performed a wide variety of field inspection work, including inspections of finished pharmaceutical and API (Rx/OTC/Veterinary Medicines) firms for general GMP and PAI purposes, BIMO/GCP inspections, medicated animal feed operations, medical devices, cosmetics, food and dietary supplement manufacturing, packaging/labeling and distribution facilities, as well as product complaint and recall surveillance activities. Bryan was also a member of the FDA’s Foreign Inspection cadre for drug inspection work. He has practical industry experience with pharmaceuticals, medical devices, dietary supplements and tobacco products/processes in the areas of development, improvement and implementation of sound Quality Systems that are efficient, sustainable, and compliant with FDA regulations. He has also performed mock FDA inspections, gap-analyses, and contractor facility audits. In addition to his professional quality and compliance experience, Bryan has over 27 years of service with the Army National Guard in both reserve and active duty tours and is currently a Colonel serving as the Director of Joint Operations for the Virginia Army National Guard.

Allen Sayler
Senior Director for Food and Cosmetic Consulting Services

Allen Sayler is the Senior Director for Food and Cosmetic Consulting Services at EAS. Mr. Sayler had been an independent consultant for EAS since 2012 and promoted in 2017.  His expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third Party Certification programs such as Safe Quality Foods (SQF) has been of great value to EAS clients.  Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee. For twelve of those years he served as vice president of regulatory affairs and international standards at the International Dairy Foods Association. Prior to that, his government career included working on dairy standards and grading programs at the Dairy Division of USDA’s Agricultural Marketing Service, FDA’s Milk Safety Branch – including a stint as acting chief of the branch and ten years as Assistant Dairy Commissioner for the North Dakota Department of Agriculture. Prior to joining EAS full time, he was a Managing Partner of the Center for Food Safety & Regulatory Solutions.  His international experience includes representing the US food processing industry at the Codex Committees on Food Additives, Food Labeling, Food Hygiene and Milk & Milk Products.

Brett Steele
Chief Financial Officer (CFO)

Brett Steele has played a key role in financial management at EAS since the company’s inception in 2006. A partner in the firm, Mr. Steele is currently the Chief Financial Officer at EAS. Prior to joining EAS full time in 2012, he had served for 14 years as a partner and vice president of RailSolutions, a consulting firm providing advisory services to financial institutions, railroads, leasing companies, shippers and fleet operators.

Independent Advisors

John Bailey, Ph.D.
Independent Advisor, Colors and Cosmetics

John Bailey Jr., Ph.D., is a former director of FDA’s Office of Cosmetics and Colors, a position he held from November 1992 through August 2002. His 34-year agency career began as a chemist in the Division of Colors and Cosmetics. He soon moved to the Division of Color Technology and advanced to become a senior research chemist. He went on to serve in other prominent agency positions including that of director of the Office of Applied Research and Safety Assessment in the Office of Science. After his retirement from the agency in 2002, he joined the Cosmetic, Toiletry and Fragrance Association as director of cosmetic chemistry, and later joined the Personal Care Products Council as executive vice president for science.

Charles Breen
Independent Advisor, FSMA Consulting Services

Mr. Breen came to EAS Consulting Group after a distinguished career at the FDA working in areas such as HACCP and LACF and BSE prohibited materials in dairy feed as well as the highly successful first domestic US follow up to BSE positive cow. Mr. Breen has worked with the industry on compliance issues related to the Bioterrorism Act of 2003 and led field and HQ professionals in developing and implementing surveillance and compliance programs, and initial FSMA training implementation. His attention to detail has garnered him an FDA Award of Merit, Outstanding Achievement and five Commissioner Special Citations.

Elizabeth Campbell
Independent Advisor, Labeling & Claims

Elizabeth “Betty” Campbell is a former Acting Director in the FDA’s Office of Food Labeling who played a leading role in writing the regulations implementing the Nutrition Labeling and Education Act (NLEA) in the 1990s. She joined EAS as a vice president in October 2006 after a 35 year career with FDA. In the role of senior advisor she will continue to provide expert consulting advice and guidance to clients on complex labeling and claims issues and will be available to serve as an expert witness in high profile labeling cases.

Nancy Chew
Independent Advisor, New Product Development and Submissions

Ms. Chew consults with a domestic and international client base on all matters pertaining to the development of new pharmaceutical and medical device applications from the development of data and studies to support the data through the regulatory enforcement after product approval. She helps prepares pharmaceutical toxicology analyses, licensing assessments, general management and strategic planning evaluations as well as regulatory research, and opinion. Her career has given her far reaching expertise in regulatory affairs and biomedical product development. She was one of two professionals who developed the regulatory affairs credential for RAPS, was elected as a RAPS fellow in 2009.

Tara Lin Couch, Ph.D.
Independent Advisor, Dietary Supplements

Dr. Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments.  She is a sought after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories.  As a consultant Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory trainings via seminar, webinar, and on-site presentations.

Susan Crane
Independent Advisor, OTC Drugs and Labeling

Susan Crane is an experienced professional in the pharmaceutical industry specializing in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations pertaining to the marketing, labeling and distribution of OTC drugs and dietary supplements: Food and Drug Administration (FDA) – Good Manufacturing Practice, Labeling, Enforcement Policy (Recalls), Dietary Supplement and Nonprescription Drug Consumer Protection Act, Consumer Product Safety Commission (CPSC) – Poison Prevention Packaging Act, Consumer Product Safety Improvement Act, OSHA Hazard Communication Standards.

Robert Fish
Independent Advisor, Quality and Compliance

Mr. Fish has been providing independent consulting services since 2003, joining EAS Consulting Group, LLC in November 2006. Prior to that he started work for AAC Consulting Group, Inc. (AAC) in April 1995 after serving 33 years with Food and Drug Administration (FDA). The last 6 years of that service he held the position of Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office for 8 years and was also a Supervisory Investigator at the Nashville District Office for 8 years. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962, and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor.

Robert Martin, Ph.D.
Independent Advisor, Food & Color Additive Safety

Dr. Robert Martin is a former deputy director of FDA’s Division of Biotechnology and GRAS Notice Review. His 38-year career at the agency included service as a research chemist and as a consumer safety office in the Division of Food and Color Additives. He became a supervisor and team leader after that division was renamed the Division of Petition Control. Dr. Martin holds a Ph.D. in chemistry from Georgetown University.

Jeffrey Springer
Independent Advisor, FDA Regulatory and Legal Matters

Jeffrey Springer is a former attorney in FDA’s Office of the Chief Counsel. His final role in a 33-year career at the agency was as Senior Advisor to the Chief Counsel. He served as Deputy Chief Counsel for 20 years. Mr. Springer is an expert in FDA regulatory and legal matters and is often called upon to serve as an expert witness in FDA legal cases.

Stephen Sundlof, D.V.M., Ph.D.
Independent Advisor, Animal and Human Food Safety

Dr. Stephen Sundlof is an internationally recognized leader in food and feed safety, who served in the agency for 18 years, including 14 years as director of the Center for Veterinary Medicine and more than two years as director of the Center for Food Safety and Applied Nutrition. Prior to joining the agency in 1994, he was a professor on the faculty of the University of Florida’s College of Veterinary Medicine.

Domenic Veneziano
Independent Advisor, Import Operations

Mr. Veneziano is a veteran FDA specialist with over 24 years of Agency experience.

He served as director of the FDA’s Division of Import Operations for more than ten years. In that role he was responsible for oversight of FDA’s import operations program and provided leadership, guidance, and direction to approximately 1,000 field investigators in more than 320 U.S. ports of entry. He also served as co-lead in the development of the FSMA import regulations and was senior advisor on the implementation of FSMA and the FDA Safety and Innovation Act. Mr. Veneziano began his FDA career in 1992 as a field investigator in the New England District specializing in medical device inspections. In 1998 he became a supervisory investigator in New England overseeing the medical device and import programs

Consultants

EAS has contracted with more than 130 FDA compliance officials and industry experts to serve the needs of our clients. Collectively, these consultants have hundreds of years of FDA and industry regulatory and consulting experience. Our team of experts are among the best available in the industry today.

This includes regulatory experts stationed in foreign countries that have knowledge of EU, Canadian and other national standards. If you are looking for an expert with a specialized skill, there is a strong possibility that we can find the right person to meet your particular need.