Registration below: GMP Training Webinars - Even better live and online
Registration below: GMP Training Webinars - Even better live and online
Providing excellence in regulatory training and quality compliance. Our full product lifecycle expertise spans pre-clinical, clinical, and operational quality environments. We build meaningful, long-term partnerships with clients across the bio/pharmaceutical, biotech, medical device, natural health, and food sectors.
Health Canada Good manufacturing practices for natural health products - Updated guidance!
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Proven, principled, and authentic, our quality consulting delivers practical training solutions and compliance‑focused support. We specialize in training and audit readiness to support successful inspections. Our services address regulatory requirements in Canada, the United States, Brazil, the European Union, and the United Kingdom. Established 2004.

Our results‑driven approach is straightforward: we strive to be the best in value, integrity, and effectiveness, serving as your trusted long‑term partner consultants.
We take a holistic approach to our regulatory consulting, working closely with clients to understand their goals and challenges. We develop solutions tailored to specific compliance needs, consistently delivering best-in-class service.

Our team comprises specialized, highly skilled professionals with extensive, diverse experience across regulated industry sectors. We work collaboratively to deliver tailored solutions that address each client’s unique needs, including support for compliant quality systems, audits, and inspections. Learn more about our team and the collective expertise that defines our role as established, credible consultants.

Steven is a experienced leader, speaker and educator with approaching three-decades of expertise in guiding complex organizations through regulatory compliance and quality assurance excellence. Skilled in collaborating across all levels, including executive teams, and specializing in tailored solutions for quality, compliance, and traini
Steven is a experienced leader, speaker and educator with approaching three-decades of expertise in guiding complex organizations through regulatory compliance and quality assurance excellence. Skilled in collaborating across all levels, including executive teams, and specializing in tailored solutions for quality, compliance, and training. Working with diverse sectors such as bio/pharmaceutical, biotech, medical devices, and natural health.
Expertise in GMP/cGMP, GCP, GLP, and regulatory compliance across multiple regions, including Health Canada, US FDA, Brazil ANVISA, EU EMEA, and UK MHRA. Proven success in designing and managing internal regulatory systems, leading inspections, conducting audits, and facilitating collaborative learning experiences that connect worldwide professionals across borders.
Steven is also a Health Canada-approved and Security Cleared Quality Assurance Person (QAP).

Dr. Swardfager has over 20 years of experience, including roles as an Associate Professor and Associate Chair of Pharmacology & Toxicology at the University of Toronto and as a Scientist at the Sunnybrook Research Institute, and he also holds a Tier 2 Canada Research Chair. His research program and laboratories integrate the principles o
Dr. Swardfager has over 20 years of experience, including roles as an Associate Professor and Associate Chair of Pharmacology & Toxicology at the University of Toronto and as a Scientist at the Sunnybrook Research Institute, and he also holds a Tier 2 Canada Research Chair. His research program and laboratories integrate the principles of Good Clinical Practices (GCP), Quality Control (QC), and Quality Assurance (QA) to ensure the highest standards of clinical research integrity, participant safety, and data reliability, and his experience includes leading multidisciplinary teams that apply rigorous QC and QA frameworks to support robust standardisation, reproducible biomarker measurement, imaging analyses, and longitudinal participant follow-up. His research contributions have been recognised through numerous distinctions, including an Academic Gold Medal from the Office of the Governor General of Canada and two international New Investigator Awards, and his commitment to education and mentorship has also been acknowledged with two teaching awards from the Temerty Faculty of Medicine at the University of Toronto.

Sanj is a senior pharmaceutical leader with 30+ years of industry experience, including Director-level and senior management roles across major pharmaceutical companies and CROs in Canada, the UK, and the US. Extensive expertise spanning bioanalytical and clinical research, clinical data oversight, protocol development and review, and ana
Sanj is a senior pharmaceutical leader with 30+ years of industry experience, including Director-level and senior management roles across major pharmaceutical companies and CROs in Canada, the UK, and the US. Extensive expertise spanning bioanalytical and clinical research, clinical data oversight, protocol development and review, and analytical method development, validation, and transfer. Deep experience across Quality Control and Quality Assurance, with end-to-end leadership of GCP/GLP/GMP compliance, audit readiness, regulatory inspections, and quality systems. Proven leader in operations, cross-functional program delivery, and complex project management.

Michelle is a experienced pharmacist with a strong record of practice across clinical healthcare and retail settings, recognized for delivering high-quality, patient-centered care. She holds a Bachelor of Science (B.Sc.) in Pharmacy from the University of Toronto and has been a Certified Diabetes Educator (CDE) since 2000, providing more
Michelle is a experienced pharmacist with a strong record of practice across clinical healthcare and retail settings, recognized for delivering high-quality, patient-centered care. She holds a Bachelor of Science (B.Sc.) in Pharmacy from the University of Toronto and has been a Certified Diabetes Educator (CDE) since 2000, providing more than two decades of specialized education, training, and clinical consultation. Throughout her career, Michelle has integrated Quality Assurance (QA) and Quality Control (QC) principles to enhance drug safety, strengthen clinical workflows, and ensure accuracy in medication-related documentation, while applying Good Clinical Practice (GCP) standards to maintain ethical, consistent, and high-integrity care. She continues to contribute meaningfully to patient wellness, interdisciplinary collaboration, and the advancement of pharmacy practice and clinical quality systems.

Onsite, remote, or hybrid - We offer collaborative and customized GMP training education in bio/pharmaceutical, biotech/clinical, medical device, and natural health sectors. Our cGMP training covers essential regulatory technical training design and facilitation required for compliance with Health Canada, US, Brazil, European Union, and U
Onsite, remote, or hybrid - We offer collaborative and customized GMP training education in bio/pharmaceutical, biotech/clinical, medical device, and natural health sectors. Our cGMP training covers essential regulatory technical training design and facilitation required for compliance with Health Canada, US, Brazil, European Union, and UK regulations, including HPFB, FDA, ANVISA, EMEA, and MHRA. Our expertise also includes support for GMP audits auditing, guidance from GMP consultants, and assistance with GMP inspections to ensure quality systems compliance.

The implementation of day-to-day internal regulatory quality systems includes trend analysis, customer and sponsor quality assessments, and qualification vendor audits. This process also encompasses internal audits, validation, change controls, deviations, non-conformances, and comprehensive risk management, including FMEA and mitigation
The implementation of day-to-day internal regulatory quality systems includes trend analysis, customer and sponsor quality assessments, and qualification vendor audits. This process also encompasses internal audits, validation, change controls, deviations, non-conformances, and comprehensive risk management, including FMEA and mitigation strategies. Additionally, it involves CAPA and root cause analysis, all crucial for ensuring GMP compliance during gmp audits and inspections. Furthermore, the development and revision of SOPs are necessary for successful, regulatory compliant business operations, supported by cgmp gmp training education and guidance from gmp consultants.

Leading Health Canada, FDA, ANVISA, EMEA, and MHRA inspections to successful conclusions while ensuring compliance with GMP standards. This includes managing government responses and correspondences effectively. We handle licence applications, updates, and renewals, alongside providing cgmp gmp training education to enhance understanding
Leading Health Canada, FDA, ANVISA, EMEA, and MHRA inspections to successful conclusions while ensuring compliance with GMP standards. This includes managing government responses and correspondences effectively. We handle licence applications, updates, and renewals, alongside providing cgmp gmp training education to enhance understanding of regulatory requirements. Our team specializes in the design and execution of internal regulatory quality systems, strategies, and solutions necessary for successful regulatory compliant business operations, including thorough gmp audits auditing to maintain quality compliance.
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