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Provide organizational optimization and expert QA support through pharmaceutical development, technical transfer, commercial manufacturing, and product discontinuation
Quality System Audits and Inspection readiness and training
FDA and EU Pharmacovigilance
Current Good Manufacturing Practice (cGMP) regulations (21 CFR Parts 210 & 211) gap assessment and remediation services to include but not limited to:
Quality by Design and Product Development, Quality Risk Management, Corrective Action and Preventive Action (CAPA), Change Control, Outsourced Operations and Supplier Quality, and Manufacturing Optimization