Sign up  

Follow Us!

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





 This email address is being protected from spambots. You need JavaScript enabled to view it.