Technical and Regulatory Expertise
Technical & Regulatory Assistance
Our technical and regulatory support is one of the key elements that set B&R Compliance Associates apart from other FDA consulting firms. B&R has over 100 years of combined regulatory and manufacturing experience, and our staff is a blend of analytical chemistry and engineering backgrounds.
The FDA compliance experts at B&R Compliance Associates are fully equipped to solve any compliance or technical problems you may encounter, and are available by phone and electronic means to answer your questions and provide support when you need it most.
FDA Audit & Agency Interaction Assistance
We have successfully guided both small and large firms to repair their compliance programs and their image with FDA following an enforcement action. If you have a 483, a warning letter, or worse B&R can show you how to get moving on the right track. With our support and guidance you can also be more effective in managing your interaction with FDA.
Adverse Event Management
Whether you are involved in a product recall, preparing a recall effectiveness report, submitting a med watch report, or are involved in an FDA compliance action B&R Compliance can help you effectively manage the process.
Our technical and regulatory support is one of the key elements that set B&R Compliance Associates apart from other medical gas compliance firms. Contact us to learn more about putting our Total Solution for compliance to work for your company.