REMEDIATION AND QUALITY SYSTEMS COMPLIANCE
BEC provides an affordable and comprehensive range of quality system remediation services for the FDA regulated industry. Our core expertise allows us to assist you in implementing risk-based, robust and sustainable solutions for your quality system. Regulatory inspections and compliance assessments frequently require regulated companies to respond to specific enforcement actions. We have comprehensive experience in developing, implementing, reviewing, and remediating all aspects of cGMP and quality systems for the FDA regulated sectors. Making your quality system compliant and sustainable while maximizing your investment is our main goal.
We provide expert compliance solutions to regulated companies including remediation strategy, planning and execution. Our expertise covers fixing your CAPA system (we wrote the best-selling book on this topic), validations, reviewing and writing technical documentation, SOPs, conducting failure investigations and preparing effective CAPAs. We also prepare our clients for successful FDA pre-approval and surveillance inspections (including mock inspections), providing support during inspections, in 483s and warning letters responses.
We also specialize in supporting foreign companies willing to market their regulated products in the U.S. We have a proven track introducing generic and OTC drugs, APIs, dietary supplements, food, medical devices and combination products into the U.S. In addition we also provide regulatory support to those companies, and we also prepare their quality systems to meet the FDA specific requirements.
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