To answer this question, one first needs to know what GxP is. The “G” stands for “Good,” and the “P” stands for “Practices.” The “x,” just as in mathematics, is a variable—it can stand for many things. Like mathematics, the trick is to “solve for x.” That’s where Compliance Team’s GxP consultants can help. Here […]
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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.
Meet and exceed product safety expectations for your customers, stakeholders and the FDA.
Having the right information and experts helps you focus on what's most important
You can count on us to be with you every step of the way to help your team succeed.
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.
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 almost 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?
Your team [Compliance Team] helped us build a streamlined, and compliant Quality System Manual. You assured our company was meeting both ISO and FDA standards. Compliance Team was an asset to our team during the ISO 13485 audit. Because of [Compliance Team's] your guidance and attention to detail, we obtained ISO 13485 certification and we were able to expand our medical device manufacturing services and customer base.
"The Compliance Team group has been instrumental in helping us with all aspects of our compliance to 21 CFR part 820 and part 11. We sincerely appreciate their level of expertise, their patience and their integrity as they guided us through interpretation of the medical device and data integrity regulations. I would recommend them to anyone needing practical advice on these topics."
Anita, Regional Director of Quality
“…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’NeilCEO, Electroskip
Regulatory and Compliance Resources
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 […]
“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 […]
Compliance Team Adds Two New Employees to Its Salesforce For Immediate Release: 8/18/2021 Buffalo, New York — Compliance Team is pleased to announce
Compliance Team's Regina Fullin was recently featured in Master Control's GxP Lifeline blog. Master Control is a software solutions company that