Member Spotlight: JE Hamilton and Associates

With a focus on helping pharmaceutical, biotechnology and other life science companies meet their quality and compliance goals,  JE Hamilton & Associates is  relocating to the AZ Techcelerator, a business incubator designed to promote and encourage promising new business endeavors.

JE Hamilton & Associates is a bioscience consultation firm that prides itself on helping pharmaceutical, biotechnology and other life science companies meet their quality and compliance goals. The firm’s three main objectives are to build internal support within the companies it serves, leave those companies with long-lasting and self-sustaining solutions to compliance issues, and provide real value by customizing the services offered to each individual client. JE Hamilton & Associates believes that a structured approach to problem solving is invaluable, and that all opinions and voices need to be heard before lasting solutions can be found.


JE Hamilton & Associates was founded by company president James (Jim) Hamilton. Jim is well qualified to lead his company to success. Before starting this new venture, he followed a distinguished and varied career path. He first served his country in the United States Air Force before attending school in New York at Niagara University. Shortly after, he started a career with the U.S. Food and Drug Administration in the Washington, DC area.

Jim held several key positions with the FDA over the years, including Regulatory Compliance Officer, and became the administration’s leading authority on import and export issues. When Jim left the FDA, he became Associate Director of Quality Assurance, Compliance and Auditing for Wyeth Pharmaceuticals before becoming Director of Global Quality and Compliance for eye-care giant Bausch and Lomb.

Jim’s diverse experience in both the public and private sector, along with his experience as a consultant for several leading pharmaceutical and biotechnology clients, makes him uniquely qualified for his role as president of JE Hamilton & Associates.


JE Hamilton & Associates offers its clients comprehensive aid in developing and maintaining superior, cost-effective quality systems by targeting four separate areas– auditing, advisement, implementation and training.

  • Auditing – The company offers its clients technical expertise and an unbiased outside look at quality assurance practices. By assembling the right, multidisciplinary team for each job and asking the tough — but fair — questions, JE Hamilton & Associates can offer insight into processes and concerns. The company even goes the extra mile by reexamining each audit with its own internal monitoring process.
  • Advisement – JE Hamilton & Associates offers clear, strong advice to clients seeking to increase compliance effectiveness, integrate compliance programs with business activities, optimize compliance costs and achieve company-wide transparency.
  • Implementation – JE Hamilton & Associates provides support to its clients when and where that support is needed. Highly effective teams, composed of associates who have knowledge of both the industry and its best practices, work hand-in-hand with the client’s internal resources to develop long-term solutions to individual projects, system designs, risk management and all phases of performance improvement.
  • Training – JE Hamilton & Associates assembles custom, in-house training programs designed to convey valuable insights and information to a client’s entire staff. Without worries about travel or housing, the people involved can focus on understanding and implementing the important concepts being presented.


In recognition of its quality services, JE Hamilton & Associates was ranked, in 2010, among a group of select bioscience firms in Arizona by the Phoenix Business Journal. The same publication featured the firm in its 2011 Book of Lists.


Most recently JE Hamilton & Associates was welcomed, in August of 2012, into the AZ Techcelerator, a business incubator designed to promote and encourage promising new business endeavors. Currently located in Phoenix, JE Hamilton & Associates will be relocating its center of operations to Surprise, Arizona, to participate in this exciting new business model.

Join the team

The company is also actively recruiting associate consultants at this time. If you feel you have the background and talent to be a part of this dynamic team and are interested in joining as an associate, please contact Jennifer E. Hamilton at jennifer.hamilton (at)


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Posted in Advocacy and Regulations, AZBio News, Members.