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Ensure your Pharmaceutical Quality System (PQS) is effective and maintains control throughout the product life cycle.

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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

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