Connect™ CMC is a state-of-the-art digital SaaS product specifically designed to meet the unique needs of pharmaceutical and biotech firms of all sizes during the crucial pre-commercial stage of drug development. By integrating every phase of the CMC lifecycle, Connect™ CMC ensures compliance, enhances operational efficiency, and significantly speeds up market entry, allowing firms to move swiftly from development to delivery.

Connect™ CMC is an out-of-the-box GxP compliant SaaS product tailored for pharmaceutical firms. It’s designed to be deployed quickly with minimal setup, offering a comprehensive suite of tools that cover every aspect of the CMC lifecycle.

Connect™ CMC provides connected and contextualized data for every batch, ensuring traceability and integrity from start to finish. It simplifies tracking and enhances the reliability of batch-related information.

Connect™ CMC automates the extraction of data from Paper Batch Records (PBRs), facilitating faster analysis and investigation. This reduces the risk of errors and increases the efficiency of data management.

With its integrated data science studio, Connect™ CMC enables customized analysis for internal reporting and regulatory submissions. This tailored approach ensures that data not only supports decision-making but also complies with regulatory expectations.

Business Benefits

Make Confidently, Release Confidently, and Comply Confidently with Mareana Connect™ CMC — an AI-powered solution designed to simplify operations for pharma and biotech companies.

Streamline Processes

Enhance Quality

Ensure Compliance

Accelerate Time-to-Market

Connect™ CMC significantly impacts the full pharma manufacturing lifecycle — from Process Engineering all the way to Quality Control.

Mareana Connect™ CMC significantly reduces manual data handling and analysis time, enhancing process optimization and validation through no-code machine learning and real-time data insights, leading to substantial time savings and improved decision-making.
Task Description Without Connect™ CMC (hours) With Connect™ CMC (hours) % Improvement
Cross-functional Collaboration 20 10 50%
Mareana Connect™ CMC facilitates scale-up activities by providing robust data analysis and management tools that ensure smooth technology transfers, equipment selection, and process optimizations, leading to faster, more reliable scale-ups with improved regulatory compliance.
Task Description Without Connect™ CMC (hours) With Connect™ CMC (hours) % Improvement
Scale-up Studies 160 70 56%
Cross-functional Collaboration 80 10 88%
Troubleshooting and Problem-solving 40 20 50%
By automating data retrieval, analysis, and reporting, Mareana Connect™ CMC streamlines compliance processes, simplifies batch record reviews, and enhances deviation management, greatly improving efficiency and reducing the likelihood of errors and oversight.
Task Description Without Connect™ CMC (hours) With Connect™ CMC (hours) % Improvement
Batch Record Review 35 15 70%
Internal Audits 80 40 50%
Deviation and CAPA Management 80 30 63%
Complaint Handling 40 20 50%
Data Integrity Oversight 10 5 50%
Mareana Connect™ CMC supports advanced analytics and visualization tools that enable researchers to derive actionable insights rapidly, accelerating the pace of clinical trials and improving study outcomes.
Task Description Without Connect™ CMC (hours) With Connect™ CMC (hours) % Improvement
Protocol Development 240 200 17%
Study Design and Planning 120 100 17%
Data Management 120 80 33%
Safety Monitoring 240 200 17%
Statistical Analysis 120 80 33%
Report Writing 240 180 25%
Documentation and Record Keeping 120 90 25%
Mareana Connect™ CMC enhances regulatory compliance by ensuring that all data handling and reporting are in strict accordance with global regulatory standards. It facilitates the preparation and submission of regulatory documents by automating many of the processes involved in compiling and validating data, thus reducing manual efforts and minimizing errors.
Task Description Without Connect™ CMC (hours) With Connect™ CMC (hours) % Improvement
Document Management 240 160 33%

Mareana Connect™ CMC

Enterprise Digital CMC Solution

Automate data management & compliance reporting across the entire drug development cycle.

GxP-Compliant & Purpose-Built

Meet GxP requirements with our purpose- built and validated solution. With built-in data integrity measures, ensure the accuracy and reliability of data for analytics and reporting.

End-to-End Data Traceability

Get end-to-end traceability of data from raw material to finished product attributes.

User-Friendly Interface

Minimize training time and maximize productivity with the best-in-class design enabling ease of use.

Enhanced Scalability

Scale effortlessly within a business with your growing data and process needs. Our cloud-based application supports both small-scale projects and large, multi-site operations

Automated Data Processing

Extract and contextualize data from paper batch records and other third- party data sources using Al & automation framework.

Typical Deployment Timeline

FAQs About Mareana Connect™ CMC

Connect™ CMC is a state-of-the-art digital SaaS product designed to streamline Chemistry, Manufacturing, and Controls (CMC) manufacturing processes. Connect™ CMC ensures compliance with regulatory standards, automatically integrates data from different source systems and data types (including paper batch records), provides data analytics with an integrated data science studio, and simplifies reporting, ultimately enhancing efficiency and reducing time to market.

Our platform is built in accordance with global pharmaceutical standards, including FDA and EMA guidelines. It is fully validated and GMP compliant.

Currently the only data source we support are Paper batch records and soon we will have measures for seamless integration with a wide range of existing systems and platforms, ensuring minimal disruption to your operations.

Data security is a top priority for us. Connect™ CMC employs advanced security measures, including encryption and regular security audits, to ensure your data is protected at all times.

We offer comprehensive support including training sessions, a dedicated customer service team, and regular updates. Our goal is to ensure you maximize the benefits of  Connect™ CMC in your operations.

Connect™ CMC stands out due to its comprehensive compliance management, Paper batch record data handling, integrated data analytics capability, user-friendly interface, and dedicated customer support. Our solution is specifically tailored to the needs of the pharmaceutical manufacturing industry, making it uniquely suited to address your challenges.

We provide extensive training for new users, including online tutorials, videos, and personalized training sessions, to ensure your team is fully equipped to use the product effectively.

Stay Ahead with
Mareana Connect™

Take your pharmaceutical manufacturing to the digital age with an AI-driven platform that empowers you to Make Confidently, Release Confidently, and Comply Confidently.

Contact Us

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