FABEL Consulting personnel are subject matter experts in FDA, EMEA and TPD inspections. We can assist you with audit readiness, our mock FDA audits can help your firm get a good read on the state of your FDA compliance. Audit reports and observations are sent within 30 days of the audit. Risk assessments are considered during the inspections. Corrective and preventive actions (CAPA) are recommended in the inspection/audit reports. We also perform due diligence audit for novel technology and asset investments.
FABEL can assist with:
FDA mock auditCrisis interventionEmergency preparedness and / or response to 483s and warning lettersThird party audit of APIs, pharmaceutical formulation plants, clinical research organization