A Commitment to Excellence

Crown College of Canada is a trusted partner for consulting and training services, renowned in the global pharma industry. With access to experts in various fields, including Quality, Compliance, Laboratory, Safety, Regulatory, R&D, and Operations, we offer tailored solutions to meet your specific needs. Our collaborative approach ensures that we work closely with you to help you achieve your goals.

Crown College of Canada Consulting Services

Quality Assurance, Computer System Validation, and Regulatory Audits
(Starting at $300 per hour)

Crown College of Canada offers comprehensive assistance in establishing and maintaining a quality system that meets GMP and regulatory requirements throughout the product lifecycle.

Our services encompass a range of quality support activities, such as Audits and Inspections, SOP development, documentation review, change control management, deviation investigation, CAPA support, stability studies, and computer system and process validation. With our deep understanding of pharmaceutical regulations and guidelines, we help clients implement effective and compliant solutions to their quality challenges.

Regulatory Affairs for Licensing Submissions and Safety Reporting
(Starting at $300 per hour)

We offer a wide range of services tailored to meet the unique needs of each client. This includes regulatory strategy development, where we assist in developing strategic plans to navigate the regulatory requirements for product development, registration, and post-approval activities.

Our experts provide guidance on regulatory pathways, submission strategies, and risk management.
We also provide support in preparing and submitting high-quality regulatory submissions, such as CTAs, INDs, NDAs, NDSs, BLAs, ANDAs, ANDSs and variations. Our team ensures compliance with applicable regulations and guidelines, streamlining the submission process and increasing the chances of successful approval.

Medical Devices Site Licensing
(Starting at $300 per hour)

Before operating in Canada, it is mandatory for your facility to obtain a licence from Health Canada for activities such as manufacturing, packaging, testing, labeling, importing, distributing, or wholesaling drug products, natural health products, or medical devices. At Crown College of Canada, our team of experts can assist you in successfully obtaining the necessary licence for your site. We provide guidance and support throughout the application process, ensuring compliance with Health Canada requirements.

Clinical Research and Pharmacovigilance
(Starting at $300 per hour)

Our consulting services for clinical research and pharmacovigilance in the pharmaceutical industry are designed to provide comprehensive support and guidance to companies involved in the development and monitoring of new drugs and therapies. For clinical research, our team of experienced experts offers a wide range of services to help clients navigate the complex and highly regulated landscape of clinical trials. We assist in protocol design, feasibility assessments, patient recruitment strategies, data collection methodologies, and study monitoring to ensure compliance with regulatory requirements and industry best practices. In pharmacovigilance, we help clients establish robust systems for monitoring and reporting adverse drug reactions and other safety-related data. Our team provides guidance on safety signal detection, risk assessment, and regulatory compliance. We assist in developing pharmacovigilance plans, implementing safety monitoring processes, and conducting safety reviews to ensure the ongoing safety and benefit-risk assessment of drug products. With our extensive knowledge of clinical research and pharmacovigilance practices, we help clients optimize their processes, mitigate risks, and ensure the safety and efficacy of their products. Our goal is to support clients in conducting ethical, high-quality, and compliant clinical research while maintaining patient safety throughout the product lifecycle.

Shopping Cart