SERVICES
Equipment, Facility and Computer System Project
At GMPharma, I’m your go-to expert for Qualification and Validation. I use the latest risk-based Computer System Validation (CSV) methods to make sure your systems are ready for inspections by the TGA, FDA, EMA, MHRA, and other regulators. With a solid scale-up and development background across the pharmaceutical, biotech, medical device, clinical research, and software industries, I’m here to help you stay on track with compliance.
At GMPharma, I’m your go-to expert for Qualification and Validation. I use the latest risk-based Computer System Validation (CSV) methods to make sure your systems are ready for inspections by the TGA, FDA, EMA, MHRA, and other regulators. With a solid scale-up and development background across the pharmaceutical, biotech, medical device, clinical research, and software industries, I’m here to help you stay on track with compliance.
GMP Readiness and Audits
I offer full-on audit services in various GxP areas worldwide, including gap analysis and risk assessment, using my team’s diverse language skills to save you time and money. My auditors are well-versed across the entire development and regulatory landscape, covering GMP readiness in compliance with TGA, FDA, MHRA, PIC/S, EU, and ISOs
GMP Readiness and Audits
I offer full-on audit services in various GxP areas worldwide, including gap analysis and risk assessment, using my team’s diverse language skills to save you time and money. My auditors are well-versed across the entire development and regulatory landscape, covering GMP readiness in compliance with TGA, FDA, MHRA, PIC/S, EU, and ISOsQuality Management System (e)QMS
I work with your team to provide hands-on support for QMS tools (Change Controls, CAPA, NCR, etc) within your quality system requirements and standards With years of experience in consulting and operational roles, I help you navigate the process and defend your CAPA systems to regulators while optimising your program.
Quality Management System (e)QMS
I work with your team to provide hands-on support for QMS tools (Change Controls, CAPA, NCR, etc) within your quality system requirements and standards With years of experience in consulting and operational roles, I help you navigate the process and defend your CAPA systems to regulators while optimising your program.