Pharmaceutical Development Compliance Services Overview
Montrium offers a comprehensive range of Quality Assurance and Regulatory GxP (GCP-GLP-GMP) Compliance services to support the different aspects of pharmaceutical development management and processes, based on proven methodology and best practices.
Montrium’s competitive advantage rests in its scope of international knowledge, the quality of its service, responsiveness to customer needs and dedication to providing superior, timely, cost-effective and value-added solutions to customer problems in pharmaceutical development
Montrium GxP Specialists/Auditors have an in depth understanding of regulatory requirements (ICH, EMA, FDA, Health Canada, etc.) and best industry practices (e.g. GAMP guidelines). Montrium GxP Specialists/Auditors have between 10 and 30 years experience in Quality Assurance, Pharmaceutical Development and Clinical Research.
These services include project, system and facility GxP Audits, Standard Operating Procedures (SOPS) Development services, GxP Document Review and Training services amongst others.
