·         Comprehensive CGMP, Quality Systems Inspections and QA Evaluations

·         Mock NDA/ANDA Pre-Approval Inspection Audits and GMP readiness Assessments which can include an investigator/chemist mock team

     for all dosage forms including combination products

·         GMP audits of Medical Device facilities and Human Tissue.       

·         GMP and FDA Inspection Training to Drug, Biotech, Biological Product Manufacturers and Medical Device manufacturers

·         Auditor Training for the Pharmaceutical auditor for all dosage forms

·         Due-Diligence assessments of vendors and suppliers

·         Sponsor/Monitor Audits

·         Q-10 Assessments

·         Pharmacovigilance Audits