About Us
HOW WE OPERATE
Our leadership team has extensive experience and a successful track record in providing prompt solutions and recommendations. Our team has over 100 years of experience to assess and meet FDA regulatory and compliance requirements; including training, efficient auditing and complete thorough documentation.
This is what we do:
- Provide superior customer care to our clients
- Respect and value our relationships with all parties
- Deliver quick efficient site visits and written documentation
- Together, bring your company into compliance.
We provide, timely, accurate, professional and thorough results. We are committed to maximizing your efforts to bring your company into compliance and meet current, as well as, future FDA regulatory and/or ISO requirements.
FDA Connection Group is an elite team of globally-certified regulatory, clinical, and quality system professionals whose track record of delivering sensible solutions assures customer needs are met. This proven commitment and credentials ensure that each client realizes superior value.
NATE WILLIAMS
President & CEO
Nate Williams, has more than 20 years experience in diverse areas of third party FDA auditing. This experience continuously contributes to the business goals of medical research client companies ranging from small start-ups to large international enterprises. This ability to devise and implement intelligent strategic plans yields superior outcomes. As Business Development Director of Hamke East Consulting, an international, third-party FDA pharmaceutical, medical device auditing Corporation, he was the key liaison between the consulting teams, the client, and FDA approval.
LAURA HAMKE
Vice President QA/RA
Laura Hamke has over 40 years of Regulatory and Compliance experience in pharmaceutics, medical devices, and biologics. Starting out as an Histologist for Syntex, developer of the “birth control pill”, she rapidly moved into Quality Assurance, then on to Regulatory Affairs. With changing times, Laura transitioned into working as an Independent Consultant for a major 3rd party consulting house. Gaining incredible experiential momentum, Laura quickly realized her well-developed skillset and went 100% entrepreneur launching Hamke East Consulting, Inc. Over the past 18 years, Laura has collected a team of experts and a long list of satisfied prestigious clients.
