Who We Are

TFS Consulting, LLC is a woman-owned consulting firm specializing in quality systems, audit readiness, and operational excellence for regulated industries. We partner with organizations that operate in complex, high-stakes environments—where compliance, integrity, and execution matter.

Our clients span medical device, pharmaceutical, and industrial sectors. Whether preparing for an ISO or FDA inspection, strengthening internal audit programs, or leading critical projects, TFS Consulting brings clarity, discipline, and results.


What We Do

We help organizations:

  • Prepare for and successfully navigate ISO, FDA and regulatory audits
  • Build, remediate, and streamline Quality Management Systems (QMS)
  • Conduct internal, supplier, and gap audits
  • Support technology transfer and operational transitions
  • Lead and recover high-risk projects
  • Develop clear, compliant SOPs and documentation

Our approach is practical and execution-focused. We help you implement systems that work in the real world.


How We Work

TFS Consulting operates as a trusted extension of your team. We take the time to understand your business, your risks, and your regulatory obligations. From there, we provide structured, defensible solutions aligned with industry standards and regulatory expectations.

Clients value us for our:

  • Direct, no-nonsense communication
  • Deep understanding of regulated environments
  • Ability to move quickly without sacrificing quality
  • Strong ethical foundation and commitment to doing the right thing

Leadership

TFS Consulting was founded by Tanya Fletcher-Scott, a seasoned quality and operations leader with decades of experience in highly regulated industries. Tanya has led audit readiness efforts, quality transformations, and complex projects across medical device, pharmaceutical, and industrial organizations.

Her leadership style blends strategic oversight with hands-on execution—ensuring clients are not only compliant, but confident.


Our Values

Everything we do is grounded in the following principles:

  • Integrity: Doing the right thing, even when it’s difficult
  • Excellence: Delivering work that meets the highest professional standards
  • Service: Supporting clients, partners, and communities with purpose
  • Accountability: Owning outcomes and following through

Who We Serve

We work with:

  • Medical device and pharmaceutical companies
  • Industrial and manufacturing organizations
  • Small and mid-sized businesses preparing to scale or enter regulated markets

Whether you need short-term support or long-term partnership, we meet you where you are.


Let’s Work Together

If you’re looking for a consulting partner who understands compliance, values execution, and treats your business like their own, TFS Consulting is ready to help.

Contact us to start the conversation.

Let us help you in your compliance journey

Mock Audits

Our team members are trained and certified lead auditors. Let us help you prepare for your first or next FDA inspection, ISO certification or other notified body.

Quality and Validation Planning

Unsure where to start? Let us help you organize your Quality and Validation Planning using a common sense risk-based approach.

Investigations and Corrective Action

Are you having trouble with CAPA effectiveness? We love investigating and driving to the root cause.