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A Regulatory Consultants Group (RGC)

Contact:   Trudy R. Papson
Specialty: Auditing, Gap Analysis, Mock FDA Inspections for Medical Devices, Pre-Approval Inspections (finished pharmaceutical/API), OTC, Generic Drugs and IVDs

Founded by former FDA investigators. From document review to walk-thru we help companies prepare for FDA Establishment Inspections, post FDA inspection analysis and FDA responses, internal audits and assistance with regulatory compliance including:


•  GAP Analysis and Internal Audits
•  Vendor Audits (suppliers, contract manufacturers)
•  FDA inspection preparation and remediation
•  FDA enforcement activity responses (483s, Warning Letters)
•  Quality systems development and improvement

 

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 949-212-2326

 

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 http://www.regulatoryconsultantsgroup.com/

 

 

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