Mareana announces the launch of Connect CMC™, a ground-breaking AI-powered software specifically designed to transform the way small pharmaceutical and biotechnology companies manage and analyze data from drug manufacturing processes. This latest offering promises to revolutionize data handling in the pharmaceutical and biotech industries, especially for companies relying on paper batch records. 

As biotech, pharma, and cell therapy manufacturers seek to modernize even while complying with audit requirements and optimizing their processes, Connect CMC™ is an ideal solution to accelerate the digital transformation in this industry. Built with GxP compliance in mind, this tool not only ensures the accuracy and reliability of data but also enhances operational efficiency and decision-making processes. 

Currently deployed by leading pharmaceutical companies in the US, Connect CMC™ significantly enhances investigation speed and analysis accuracy. It optimizes processes, fostering operational excellence through automation while simplifying regulatory submissions. 

Key Features of Connect CMC™:

• AI-powered Automation: Streamlines data extraction, ensuring efficiency and accuracy.
• Scalability and Cost-Effectiveness: Adapts to growing data and process needs for both small-scale    and large, multi-site operations.
• Intuitive User Interface: Minimizes training time and maximizes productivity.
• Consolidated Knowledge Hub: Facilitates collaboration across teams and with external partners.
• Comprehensive Traceability and Audit Readiness: Offers end-to-end data traceability and built-in audit capabilities.

“Connect CMC™ is designed to streamline drug development, providing instant support for investigation and analysis at a fraction of your current cost,” states Vishal Prasad, Co-Founder, and Chief Product Officer at Mareana Inc. 

“Our vision for Connect CMC™ is to provide customers a fully validated system that overcomes many challenges faced by the industry and allows organizations to increase investigation speed and accelerate time to market. Our product is designed for scalability and efficiency, while leveraging AI to intelligently connect data, business processes, and compliance requirements,” says Prashant Kumar, Co-Founder & CEO of Mareana Inc. 

Targeted at companies using paper batch records and those collaborating with Contract Development and Manufacturing Organizations (CDMOs), Connect CMC™ not only speeds up the data analysis process but also assists in timely batch record release and comprehensive audit preparations. It is now available as a Software as a Service (SaaS) offering hosted on Mareana’s validated cloud platform.