Regulatory and Quality (RA/QA)
for the Life Sciences Sector

RaaSdesk is our advanced platform for comprehensive management of regulatory affairs. It facilitates communication with authorities, regulatory document management, and preparation for audits and regulatory reviews.

Benefits of RaaSdesk:

• Simplification of regulatory document management.
• Improved efficiency in communication with regulatory authorities.
• Compliance with regulations and accelerated approval timelines.

ARI is our automated regulatory intelligence solution that uses AI to optimise regulatory decision-making. It helps identify relevant regulations and simplifies regulatory processes, ensuring real-time compliance.

Advantages of ARI:

• Optimisation of regulatory decision-making through artificial intelligence.
• Reduction of human error and improvement in operational efficiency.
• Access to updated and relevant information for regulatory compliance.

AReIA is an advanced virtual assistant that helps interpret complex regulations and manage regulatory compliance. It automates the collection and management of regulatory documents, reducing response times and improving process quality.

Features of AReIA:

• Assistance in interpreting national and international regulations.
• Efficient management of regulatory documentation.
• Continuous improvement of regulatory compliance.

Praas is our solution for conducting periodic reviews of IT systems, ensuring all systems in use are up-to-date and compliant with regulatory requirements. This service helps detect deviations and enables proactive corrective actions.

Benefits of Praas:

• Continuous review of IT systems.
• Identification of deviations and improvement recommendations.
• Compliance with regulations such as GxP, Data Integrity, and more.

eQMS is our digital quality management platform that automates document management, audits, and regulatory compliance processes. It ensures compliance with standards like ISO 9001, GMP, and more.

Advantages of eQMS:

• Automated quality and regulatory process management.
• Error reduction and operational efficiency improvement.
• Compliance with international quality standards.

QMSuite is our comprehensive platform that integrates quality and regulatory affairs, facilitating compliance with international standards. From audit management to system integration, QMSuite optimises all regulatory and quality aspects.

Benefits of QMSuite:

• Full integration of quality and regulatory affairs in a single platform.
• Increased efficiency in audit and regulatory document management.
• Compliance with international standards and regulations.