GxP Consulting Corporation (GCC) specializes in supplier management and auditing solutions for the Pharmaceutical, Biotech, and Medical Cannabis sectors. We offer expert consulting, GMP training, and auditing services to help life sciences companies and their suppliers maintain GxP compliance.
We help pharmaceutical companies implement a GxP compliant and sustainable quality management system.
Headquartered in Toronto, GCC is a global network of specialized GxP consultants serving the pharmaceutical, biotech, and cannabis industries. We offer end-to-end consulting solutions designed to navigate complex supplier management and regulatory landscapes. Our expertise spans Quality Assurance and Control, Regulatory Affairs, and Validation, alongside deep proficiency in Good Manufacturing (GMP), Laboratory (GLP), Clinical (GCP), and Health Canada Medical Cannabis Good Production Practices (GPP). We also specialize in regulatory submission support (including Cannabis Licensing Applications), preparation for Health Canada and US FDA audits, third-party auditing, SOP development, and critical technical services such as temperature mapping studies.
Comprehensive Good Manufacturing Practice audits for pharmaceutical, biotech, and cannabis facilities. Our experienced auditors assess your operations against current regulatory requirements, identify compliance gaps, and deliver actionable reports to strengthen your quality systems and inspection readiness.
Specialized audits aligned with ISO 13485 requirements for medical device quality management systems. We evaluate your design controls, production processes, and post-market surveillance programs to ensure your organization meets international regulatory expectations and maintains certification readiness.
Targeted audits of primary packaging material suppliers in accordance with ISO 15378, the GMP standard for primary packaging materials for medicinal products. We assess supplier quality systems, material specifications, and traceability to help you manage packaging supply chain risk effectively.
Audits conducted against Good Production Practices (GPP) and Good Agricultural and Collection Practices (GACP) standards for cannabis and natural health product operations. We evaluate cultivation, harvesting, processing, and quality control practices to ensure compliance with Health Canada and EU-GACP requirements.
Supplier audits focused on excipient manufacturers and distributors in alignment with the Joint IPEC-PQG GMP Guide and applicable regulatory expectations. We assess manufacturing controls, testing protocols, and supply chain integrity to help you qualify and monitor your excipient suppliers with confidence.
Independent audits of contract testing laboratories and analytical service providers. We evaluate GMP/GLP compliance, method validation practices, data integrity controls, and laboratory information management systems to ensure the reliability of outsourced testing and the integrity of your product release decisions.
Customized on-site and virtual GMP training programs tailored to your team's roles and experience levels. Our courses cover core GMP principles, data integrity, documentation best practices, CAPA management, and inspection readiness — designed to build a culture of quality and compliance across your organization.
End-to-end GxP consulting solutions including quality system development, SOP writing, regulatory submission support, vendor qualification programs, temperature mapping studies, computer system validation, and Health Canada or FDA audit preparation. We work alongside your team to implement sustainable, inspection-ready quality management systems.
Key regulatory references, databases, and guidance documents for the pharmaceutical and life sciences industry.
Ready to achieve GxP compliance? Reach out to our team of experts today.