Quality Assurance
Assist in demonstrating and providing confidence that the quality requirements are defined, fulfilled, and sustainable.
Quality Management System
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Design, develop, & establish quality standards to support facility, process, and product
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Evaluate and improve quality systems
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Reduce regulatory burden
Process & Infrastructure
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Assess process controls
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Process characterisation and optimisation
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Risk assessment and mitigation
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Facility and services design
Product
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Define quality and regulatory requirements
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Risk assessment and mitigation
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Link product quality attributes to process control
Compliance
Assist with product, process, and regulatory commitments.
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Build Quality Management System (QMS)
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Process and product technology transfer
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Process characterisation and optimisation
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Perform product, process and compliance risk and gap assessments
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Design, commission, qualify and validate facilities, plant, equipment, and process
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Rectify and resolve compliance and regulatory matters
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Aid and work with certification and regulatory bodies
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Conduct, assist, or manage audits and inspections
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Remedy identified or probable deficiencies
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Educate, lead, and mentor industry professionals and professional associations
Interested in our Audit and Inspection services?
Interested in our Compliance services?
Regulatory
Aid in registration, licensing, and clinical studies.
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Facility licensing
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Product registration
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Prepare, compile, and review submission dossiers
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Design and manage clinical studies
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Manage data and evaluate statistics
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Prepare submissions
Komply use and apply relevant recognised codes of Good Manufacturing Practice (GMP) and international standards.