Life Science Compliance Consultants, serving the Clinical Research, Pharmaceutical and Medical Device Industries.

Our compliance consultants work to bring lifesaving products to market.  By teaming up with our trusted experts, your company gains the confidence that your medical product design, clinical research operations, or manufacturing & validation processes meet FDA regulatory & compliance standards at every stage of development.

Minimized Risk

Meet and exceed product safety expectations for your customers, stakeholders and the FDA.

Guided Focus

Having the right information and experts helps you focus on what's most important

Trusted Partnerships

You can count on us to be with you every step of the way to help your team succeed.

Proven Results

CT provides regulatory solutions that meet or exceed domestic and international standards.

Manufacturing a drug or medical device?

No matter how large or small the project, Compliance Team is ready to manage the regulatory details throughout your medical product life cycle.

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We’re here to minimize risk and complexity.

Our solutions allow your company to focus on growing your business without delays or interruptions due to regulatory requirements. For over 20 years, our compliance consultants have worked to bring lifesaving products to market. What could your company accomplish if it had a partner like Compliance Team?
  • “…Compliance Team was credited for having the flexibility to understand the repercussions of various risk-based options, assuring qualification coverage via a less-restrictive method.”
  • “Compliance Team was also instrumental in authoring the Quality Plan, a Validation Master Plan, Validation Plans, Validation Risk Assessments, and the Validation Project Plan for all of these systems…”
  • Thanks again for all your help, we hope to continue working with Regina as much as we can, she has been a perfect fit for us.
    Jamie O’Neil
    CEO, Electroskip

Regulatory and Compliance Resources

What are the regulations for cleaning validation ?

What are the regulations for cleaning validation ? By: Amanda Gainey, Compliance Team Validation Associate Pharmaceuticals Cleaning validation in the pharmaceutical industry refers to cleaning product contact surfaces of pharmaceutical manufacturing, packaging, and support equipment (e.g., product contact screens, utensils, etc.). The validation must demonstrate and document that cleaning procedures effectively and consistently reduce product […]

Making Anything, Anywhere with 3D Printing

“Our vision for the future is the idea that anyone can make anything,” said Joshua Niman, sales engineering lead at Formlabs. Speaking in the Virtual Engineering Days presentation, “Anywhere Manufacturing: Overcoming Barriers to Product Using Additive Manufacturing,” Niman said that this is where he sees additive manufacturing changing the world and impacting industry. “We feel like we’ve really elevated […]

12 Things to Know About 3-D Medical Printing

3D printing was born in France – 3D printing, invented in France in 1984, emerged in the 21st century as a commercial technology with a variety of biocompatible materials available to medical device manufacturers. 3D printing comes in a variety of flavors – The FDA refers to 3D printing as additive manufacturing (AM). Powder bed […]

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