QUALITY SYSTEMS & POST-MARKET COMPLIANCE
Compliance, Rules & Standards
Quality Systems
1. Quality Systems Implementation
We offer full consulting services for establishing the US FDA QMS requirements. In general, the quality systems (QS) represents the cGMP (Current Good Manufacturing Practice) requirements for the FDA-regulated products (such as, drugs, biologics, and devices). For medical devices compliance, cGMP requirements are covered under the requirements set forth in 21 CFR § Part 820 and ISO 13485 Compliance.
2. Corrective and Preventive Action (CAPA)
We provide consulting support and guidance about the corrective and preventive action subsystem management which applies to collecting, analyzing, identifying, and investigation of product and quality problems, including further appropriate and effective corrective and/or preventive action compliance.​​
Post-Market Compliance
Medical Devices
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Post-Market Complaints Management
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Mandatory Complaints Reporting (MDRs, EC Vigilance, MPRs)
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Warning Letters/483s Responses
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Pharmaceuticals Adverse Events (AEs) Reporting
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EU Authorized Representative (AR) Management
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EU Notified Body (NB) Transfer & Management.
Recalls & Remediation
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Global Recalls Reconciliation
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Recall Remediation Strategies
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Global Recall Response Letter, Notifications and Communications.
