Professor Hulihan is among the most talented in the industry. It would be our pleasure to put our extensive experience to work for you.
A brief glimpse of ‘GXP’ Audit Areas include: Sponsor, Monitor, Investigator, CRO, GCP [Drug, Biologic/Vaccine], Laboratory [GLP, Non-Clinical], cGMP [selected focus areas], Medical Device, Pharmacovigilance and Drug Safety, Submissions, Electronic Submissions, Electronic Systems, Validation of Computer Systems, Fraud Determination.
We have conducted over 500 ‘GXP’ audits worldwide - examples include the following countries: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, England, Finland, France, Germany, Hungary, India, Ireland, Israel, Japan, Mexico, Netherlands, Norway, Peru, Spain, Sweden, Switzerland, United States, Uruguay, Wales
Contract Quality Assurance Inspections - Domestic and International: Good Clinical Practice (Investigator, Sponsor / Monitor, IRB, CRO/Technology Vendor); Clinical Research Assessment; Pharmacovigilance and Drug Safety, Computer Systems Validation; Data Management; eDC (Electronic Data Capture); RDE (Remote Data Entry); RSM (Remote Study Monitoring); Pen / Text / Transmission Systems; Code Risk Assessment, Information Systems; Statistical; Technical Writing; Good Laboratory Practice; Good Manufacturing Practice [selected focus areas]; Medical Devices, Manufacturing Process and Controls, Nuclear Imaging, Pen / Palm Based Systems, Pacemaker, Implant, Pump Technology, SAP
Expertise Includes GXPs - GCPs (including Drugs, Biologics, Devices); GLPs (including Bioanalytical, Bioequivalence, Phase I Laboratories); cGMPs (including Device, Manufacturing, Pharmacovigilance and Drug Safety, Process and Controls, Process Validation, Computerized Systems Validation, Manufacturing Control/Monitoring Systems, Human Machine Interface Systems, Supervisory Control and Data Acquisition Systems); Systems Assessments (including Computer, Data Management, Statistical, Regulatory Compliance, Regulatory Submissions, Technical Writing), Devices, International Regulatory Compliance, Device Validation, Construction of Evidence, Remote Data Entry, Remote Study Monitoring, Fraud Identification, Computer System Validation, Pen Based Systems, Pacemaker, Implant, Pump Technology, Fax Technology