Senior Consultant@ Global PharmaDevice Solutions
Skokie, Illinois, United States
MATTHEW AZUH
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FlashIntel GPTMATTHEW AZUH is a highly experienced quality and regulatory compliance professional with over 23 years of industry experience in pharmaceutical, biotechnology, and medical device industries. He has expertise in FDA regulations, GMP, validation, and quality system architecture. With a strong background in regulatory submissions and clinical trial management, MATTHEW has served in key quality assurance, quality control, and regulatory affairs management positions for over 18 years. He has worked at Global PharmaDevice Solutions in various roles, including Principal Regulatory Compliance Consultant and President/CEO.
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A quality & regulatory compliance professional with over 23 years of industry experience in pharmaceutical, biotechnology and medical device industries. Areas of leadership and expertise include consent decree management, CAPA/MDR/AER file remediation, quality system architecture, laboratory management, regulatory submissions, clinical trial management, (GxP) auditing, lead auditor training, FDA (NDA, 510K, CLIA, PMA) petition/submission, Time and Extent Application (TEA) for foreign marketed drugs, domestic/international cold chain validation, software validation, aseptic processing, project management, supplier/source development and management. Served in key quality assurance, quality control, and regulatory affairs management positions and decision making roles for over 18 years.
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Senior Consultant
Principal Regulatory Compliance Consultant
President | Chief Executive Officer
President | Chief Executive Officer
Pharmaceutical Manufacturing
MATTHEW AZUH's Professional Milestones
- President | Chief Executive Officer (2003-01-01~): Transformed company culture and strategic decision-making, resulting in significant revenue growth and company expansion.
- Principal Regulatory Compliance Consultant (2003-09-01~): Providing exceptional regulatory guidance based on client requirements, ensuring seamless operations and a regulatory framework.
Skill
Fda
Gmp
Validation
Quality System
Regulatory Affairs
Medical Devices
Biotechnology
Quality Auditing
Pharmaceutical Industry
Capa
Gcp
Quality Assurance
Quality Control
Pharmaceutics
Laboratory
Gxp
Glp
Iso 13485
Regulatory Requirements
21 Cfr Part 11
V&v
Auditing
Change Control
Aseptic Processing
Lifesciences
Technology Transfer
21 Cfr 820
21 Cfr 201/211
Iq/oq/pq
Cgmp Training
Ivd
Medical Device
Certification
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MATTHEW AZUH works for Global PharmaDevice Solutions
MATTHEW AZUH's role in Global PharmaDevice Solutions is Senior Consultant
MATTHEW AZUH works in the industry of Pharmaceutical Manufacturing
MATTHEW AZUH's colleagues are MATTHEW AZUH,Sierra Przystal
MATTHEW AZUH's latest job experience is Senior Consultant at Global PharmaDevice Solutions
