BioExpert International Inc.

BioExpert International is a Canadian pharmaceutical and biotechnological consulting firm that focuses on quality and regulatory compliance. BioExpert International helps customers improve productivity, performance and profitability using innovative services and technologies and a deep understanding of their industries and applications.

With an extensive knowledge and expertise in the fields of biotechnology including: pharmaceutical, medical devices services, and food science, Bioexpert is exclusively dedicated to businesses wishing to shorten the time to complete their documents related to regulatory, compliance affairs and solutions with Health Canada, FDA, and CE mark.

We play a key role in quality assurance, pharmaceutical products design and development, formulations and scale-up production batches, including total packaging solutions.

Being very familiar to the rules and regulations implied by cGMP, HACCP, and ISO , Bioexpert can also be of great assistance in pre-auditing your firm and prepare you for the necessary certifications you are desiring. Our services encompass the entire project life cycle, and a complete range of services including facilities compliance, utilities validation, and all types of production and sterilization processes. We manage and execute full implementation of quality manual, including development of validation master plans and requirements; development and execution of installation qualifications, operational qualifications and performance; and the performance of individual tasks associated with a client’s validation efforts.

Our mission is to contribute to the success of our clients by providing them with Regulatory Compliance Solutions.