About FCG
About FDA Connection Group Inc.
Get hands-on expertise, practical solutions, and real-world results.
FDA Connection Group Inc. combines regulatory strategy, submission operations, quality and compliance experience, and eCTD execution to support pharmaceutical, biotechnology, medical device, and biologic companies at every stage of product development.
Who We Are
FDA Connection Group Inc. is a specialized regulatory consulting and submission services company focused on helping life sciences organizations bring innovative therapies to market.
We combine deep regulatory knowledge, practical experience, and a hands-on approach to solve complex challenges, streamline submissions, and support your program from IND to BLA and beyond.
How We Operate
Our Guiding Principles
We work as an extension of your team, combining strategic insight with practical, hands-on execution.
Client Focus
Your goals drive our strategy and execution.
Practical Solutions
Real-world, actionable approaches that work in today’s regulatory environment.
Submission Quality
Meticulous, compliant submissions with attention to detail.
Responsiveness
Proactive, accessible communication throughout your program.
Regulatory Clarity
Clear guidance through complex requirements to keep your programs on track.
Our Leadership
Experienced Leaders. Practical Solutions.
FCG is led by industry professionals with deep regulatory, submission, and quality experience.
Nate Williams
Founder and Principal
Nate Williams brings extensive experience in regulatory strategy, submission operations, and quality/compliance across pharmaceutical, biotechnology, and medical device programs. He is known for developing practical, efficient solutions that help clients navigate complex regulatory pathways and achieve successful submission outcomes.
Laura Hamke
Founder and Principal
Laura Hamke has deep expertise in eCTD submissions, regulatory operations, and lifecycle management. She has supported hundreds of regulatory submissions, helping clients ensure compliance, data quality, and efficient, solution-driven processes. Laura is passionate about building strong client partnerships and delivering high-quality, reliable results.
Entrepreneurial Leadership. Regulatory Execution. Built to Adapt.
FDA Connection Group Inc. was built from a career shaped by operations, reinvention, entrepreneurship, and regulatory consulting.
Founder Geoffrey Nate spent 15 years with TWA, including 10 years as a flight attendant and five
years in West Coast regional management with responsibility across airport operations in the region. Following a major transition in the airline industry, he decided to rebuild his career from the ground up.
At age 47, he returned to school and pursued a degree in business entrepreneurship, completing the program in 2015. He later launched Healthcare Getaways, a medical travel business that was building momentum before the COVID-19 pandemic disrupted the industry.
His connection to regulatory consulting began years earlier through work with Hamke East Consulting, launched in 2003, an era when regulatory meetings and document reviews were frequently conducted in person. During the pandemic, those regulatory roots became part of a renewed professional collaboration.
Geoffrey subsequently launched FCG and increasingly focused the company on FDA regulatory operations and electronic submissions. As the industry shifted toward remote work and eCTD became central to FDA submission activity, FCG’s publishing and submission capabilities expanded alongside its regulatory strategy work.
Today, FCG combines regulatory strategy, regulatory operations, quality experience, and hands-on eCTD execution—and is developing FCG-OS™ as the next step in structured regulatory program intelligence.