Our global services include a comprehensive assessment to help identify gaps and opportunities, a targeted project plan with timelines / milestones as well as an agreed upon schedule based on deliverables. We also offer add on services including a suite of software applications to help automate and validate critical compliance processes to assure long term success and audit readiness. Core Competencies include: ❖21 CFR 211 (GMP), 820 and ISO 13485 System Builds and Support ❖ GMP Training and Coaching❖ FDA Inspection Preparation, War-rooms, Execution and Remediation❖ Internal and 3rd Party Audit Preparation and Execution❖ Computer System Selection, Support and Validation (IQ/OQ/PQ)❖ Facility, Equipment and Process Commissioning and Validation❖ Supplier / Material Qualification and Remediation❖ Risk Assessment, Determination and Mitigation❖ Adverse Event, Complaint Handling and Annual Product Review❖ Change and Deviation Management❖ Retain and Quarantine Requirements❖ CAPA and Out of Specification Management❖ DEA Regulations and Requirements❖ Board of Pharmacy Warehouse Requirements