Your Trusted Life Science Compliance Consultants
Our core group of engineers, scientists, regulatory and quality experts are here to guide your business through FDA manufacturing inspections, quality audits, equipment validation, and regulatory product submissions.
It's our job to bring you the right expertise at the right stage of your project.
Our compliance support strengthens your life science operations and product safety
Since 2003, Compliance Team has protected hundreds of life science companies by assuring their manufacturing quality systems, engineering validation programs and clinical studies consistently meet compliance standards. Our knowledge of FDA, ISO, EMA, Health Canada, and other regulating bodies secures you and your customers from costly regulatory and compliance oversights.
What Our Clients Value In Us
We work to bring life-saving products to market.
Expert Advice
Lighten the Load
Deep Understanding
Quick Response Times
Testimonials
Anita
“Compliance Team as 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, patience and 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.”
Jamie O’Neil
“Thanks again for all of your FDA regulatory and quality help, we hope to continue working with Compliance Team as much as we can, you have been a perfect fit for our business.”
John Longuil
“Your 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 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.”
