Your Trusted Partner to Sustainable Compliance
International Compliance Services Maven and Associates
International Compliance Services Maven and Associates has a proven track record to support you in your journey through the complex maze of quality, compliance, and regulatory challenges.
We Provide:
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Scalable and trustworthy quality and compliance services when your experience needs ours.
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Quality management system design, implementation, and training.
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Site preparation for regulatory authorities inspection (FDA, MHRA, EMA, PMDA, ANVISA, AHPRA, etc.) plus hands-on support during the inspection.
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Strategic planning and advice in relation to compliance with all applicable FDA and EMA regulations and directives; including title 21 CFR parts (210, 211, 11, and 600), ICH quality guidelines (Q7, Q8, Q9, Q10, Q11, and Q12), GAMP5, PIC/S, and ISO 9000.
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Support for preparation of successful BLA and NDA applications.
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Qualification and Validation services for Facilities, Utilities, Equipment, and products.
We will augment your team with the most important intangible element in our industry,
EXPERIENCE.
Quality Management System:
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Design and implementation
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Prepare policies, standards, and procedures
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Global QMS launch
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Training and mentoring
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E-System interface (TrackWise, MasterControl, etc.)
Validation:
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Master planning
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Facility, utility, & equipment qualification
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Process validation
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Cleaning validation
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Computer system validation (manufacturing systems, management systems)
Inspection Management:
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Inspection readiness
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Baseline assessment
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Mock inspection
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Prepare response to observation
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CAPA and remediation actions
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Meeting with regulatory agencies
Documentation Management:
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Prepare site master file
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Prepare QA/QC, and operational procedures
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Annual product review report
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Prepare and/or review regulatory files (NDA, BLA, etc.)
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Prepare and deliver subject specific training modules
Data Integrity Management:
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Digital data integrity
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QC laboratory record
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Production record (manual and electronic) data
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Audit trail review
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Systems interface and data transfer review
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E-signature & access management evaluation
Risk Management:
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Risk assessment
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Risk review
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Quality risk mgt. in CAPA
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Quality risk mgt. in qualification
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Risk control
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Risk mitigation
Meet Our Team
