Software for the Pharmaceutical Industry

The pharmaceutical industry in the Netherlands is among the most heavily regulated sectors in the world. Large pharma companies and emerging biotech firms must comply with strict GxP guidelines (GMP, GLP, GCP) and report to regulators such as the EMA and CBG-MEB. At the same time, pressure mounts to shorten R&D cycles and increase supply chain transparency. Custom software makes it possible to manage clinical studies more efficiently, automate compliance processes, and digitally track the entire chain from raw materials to patient. MG Software builds validated systems that meet 21 CFR Part 11 and Annex 11 requirements.

Pain points

• Manual management of clinical trial data in spreadsheets, leading to errors and delays in regulatory submissions
• Complex GxP compliance requirements (GMP, GLP, GCP) that are difficult to guarantee with generic software
• Lack of end-to-end supply chain visibility, from raw material procurement to pharmacy distribution
• Time-consuming reporting to regulators (EMA, CBG-MEB) due to fragmented data systems and manual consolidation
• Difficult collaboration between R&D departments, CROs, and external laboratories without a centralised platform

Our solutions

• Clinical Trial Management System (CTMS) with automated patient enrolment, monitoring workflows, and real-time study dashboards
• GxP-validated document management system with electronic signatures compliant with 21 CFR Part 11 and Annex 11
• Supply chain tracking platform with serialisation, temperature monitoring, and batch traceability from raw material to pharmacy
• Automated regulatory reporting engine that consolidates data from multiple sources and generates submissions in eCTD format
• Collaboration portal for R&D teams, CROs, and external partners with role-based access and full audit trail

Benefits

• Up to 30% faster clinical study timelines through automated workflows and real-time data insight
• Full GxP compliance with validated systems meeting EMA, FDA, and CBG-MEB requirements including audit trail
• Lower costs for regulatory submissions through automated data consolidation and eCTD generation
• Complete supply chain traceability with serialisation and temperature monitoring in accordance with GDP guidelines

Technologies