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Technical and Regulatory Expertise
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Technical & Regulatory Assistance - With over 50 years of combined regulatory and medical gas manufacturing experience and our analytical chemistry and engineering backgrounds the experts at B&R Compliance Associates are equipped to solve any compliance or technical problem you may encounter.
Unlimited Support - Our Total Solution customers enjoy full access to the B&R experts by phone and electronic means to answer your questions and provide support.
FDA Audit & Agency Interaction Assistance - We provide a specialized support service for Total Solution customers undergoing FDA inspections. With our support and guidance you can be more effective in managing your interaction with the agency, as well as responding to any notices of observation (483) or FDA warning letters you receive.
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.
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