Integrated solutions provider - quality compliance, regulatory & training (full product lifecycle) — from pre-clinical (GLP) and clinical (GCP) to manufacturing, production (cGMP/GMP, GPP) and HACCP food safety. Partners with the bio/pharmaceutical, biotech/clinical, medical device, natural health and food sectors.
Proven, principled, authentic, leading-by-example, strategic, consulting expertise in quality management, regulatory affairs, training and GMP, GxP, GCP, GLP, GPP, and natural health regulatory compliance, encompassing the requirements for Canada, US, Brazil, EU and the UK.
Est. 2004.
Our team at Global QRP is made up of niche highly skilled professionals with diverse backgrounds. We work together to provide our clients with tailored solutions that meet their unique needs. Meet our team and learn more about our individual areas of expertise.
At Global QRP, we take a holistic approach to training and consulting. We work closely with our clients to understand their goals and challenges, and develop solutions that address their specific needs. Our approach is simple... best in price, best in class, honest, transparent, effective and results-driven.
Leading Health Canada, FDA, ANVISA, EMEA and MHRA inspections to successful conclusions.
Government responses/correspondences.
Licence applications, updates and renewals.
Design and execution of internal regulatory quality systems, strategies and solutions required for successful regulatory compliant business operations.
Implementation of day-to-day internal regulatory quality systems including trend analysis; customer/sponsor quality & qualification vendor audits, internal audits, validation, change controls, deviations, non-conformances, risk management/FMEA & mitigation, CAPA and root cause analysis.
Development and revision of SOPs required for successful, regulatory compliant business operations.
Onsite, remote or hybrid - Collaborative and customized bio/pharmaceutical, biotech/clinical, medical device, natural health GMP/cGMP, GCP, GLP, and GPP regulatory technical training design and facilitation, required for Health Canada, US, Brazil, European Union and UK regulatory compliance | HPFB, FDA, ANVISA, EMEA, MHRA.
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