
Montrium has a deep understanding of both the drug development landscape and regulatory submissions which has formed the basis of our RegDocs Connect solution. RegDocs Connect helps you author and manage your content both pre and post-submission in an intuitive, easy to use and compliant environment

Montrium recognizes that the TMF holds a significant wealth of information which is of strategic importance for the successful conduct and reporting of clinical trials. Using in-depth knowledge of clinical processes and the TMF Reference Model, the eTMF Connect software tool has been designed for users like you working at the heart of the clinical trial

Montrium has designed its enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud
Montrium is a life sciences software company founded in 2005 that modernizes how scaling biotech, pharmaceutical companies, and CROs manage regulated content and compliance. Headquartered in Montreal, Canada with offices in Brussels, Belgium, Montrium serves organizations worldwide. Built by GxP compliance and validation experts with decades of experience in regulated environments, Montrium's products are designed by teams who have spent their careers implementing and validating systems for clinical trials and quality management. This deep industry expertise ensures solutions address real operational challenges rather than theoretical requirements. Montrium offers three software products: eTMF Connect for Trial Master File management, Quality Connect for quality management systems, and RegDocs Connect for regulatory submissions. Professional services include eTMF consulting led by seasoned GCP experts, Adobe Sign validation toolkits, and implementation support with included validation packages. Montrium's mission is to empower growth-stage life sciences organizations with affordable, easy-to-use technology that maintains regulatory compliance without enterprise-level complexity or cost. Your intelligent content management for life sciences