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
Mohsen Eghbal
Managing Director
Mohsen is a GMP, Quality, Compliance and regulatory professional with over 35 years of experience as a hands-on manager, strategic leader, and executive within the pharmaceutical, chemical, medical device, and biopharmaceutical industries.
Dr. Thomas A. Lang
Senior Associate
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Tom is a highly regarded senior level regulatory affairs executive with over thirty-five years of experience in the pharmaceutical and biotech industry with a Bachelor of Science Degrees in Chemistry and Pharmacy, MBA, and Ph.D.
Tony McDonagh
Senior Associate
Tony is an experienced Enterprise CSV/DI and IT Applications consultant with over 35 years of experience implementing and supporting business and Quality Systems across a variety of Life Science companies.
Dr. Carlos Herrero Sanchez
Senior Associate
Carlos has over 28 of experience in Pharmaceutical Industry with over 20 years of experience managing Quality Assurance, Quality Control and Compliance within Pharmaceuticals, Vaccines, and Chemical API companies
Jeff Jackowski
Senior Associate
Jeff has over 35 years of experience in quality assurance and regulatory compliance within pharmaceutical and biopharmaceutical industries. He is an expert in design and implementation of quality management system, validation, and all related GXP subjects.
