About Us
Experience You Can Count On
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
Learn More
Our highly interactive and collaborative approach assures meeting remediation goals on time, on scope and on budget. Our team has the bench and experience level to tackle any type of internal compliance issue or external vendor quality challenge.
Our Partners
