Drive Innovation and Regulatory Compliance with Trusted Life Science Data

Maintain complete and accurate records of all your product data throughout its entire lifecycle. Have full traceability – from raw materials and ingredients to finished goods – to more easily comply with industry standards like GS1 and GDSN. This is crucial for pharmaceutical, biotechnology and medical device companies that need to meet regulatory requirements set by agencies like the FDA and EMA.

Simplify data exchange with partners and regulatory bodies – including during audits – and reduce the risk of non-compliance. By staying in full control of your product information, tracking every change and ensuring data is accurate throughout the product lifecycle, you will have confidence in your data and your ability to meet regulatory demands.

Simplify regulatory reporting and navigate the complex global regulatory landscape more easily. Use extensive data governance tools to ensure all your product, material and supplier data is validated and maintained in line with industry regulations such as GxP, ISO and GDPR.

As part of your R&D and clinical data management, define data quality rules, automate data validation workflows and generate audit trails to track data changes and ensure compliance.

Use pre-built templates and reports for common regulatory submissions, reducing manual effort and ensuring accuracy.

Gain complete visibility and traceability across your supply chain. Maintain a master record of materials, efficiently manage supplier data and material taxonomy, and ensure accurate information is available throughout the whole procurement and manufacturing process.

Use effective tools for tracking material sources, managing expiration dates and monitoring supplier performance. You can also generate reports on material usage, identify potential risks and respond effectively to any supply chain disruptions.

Boost your research and development teams with a centralized repository for all critical research data. Create a collaborative environment for managing research data, so your teams can efficiently share and analyze data.

Track clinical study, assay and trial data and collaborate on research projects securely, all while adhering to compliance requirements.

By removing data silos and giving your R&D organization and clinical operations easy access to accurate information, you speed up innovation and make drug and medical device development smoother across the board.

Manage your supplier network more effectively and maintain a high quality of your pharmaceutical and medical device materials. By centralizing all your supplier data, you get a complete view of supplier performance, material taxonomy and attributes, and compliance information.

Quickly and easily onboard new suppliers, manage supplier documentation and track performance metrics – all in one place. Our solution also helps you remain compliant with supplier quality standards and regulations.

In other words: You both reduce risks and improve efficiency in your supply chain.

Manage data for the entire lifecycle of your products, supporting compliance and safety at every stage, from development to post-market surveillance.

Support your pharmacovigilance activities by capturing and managing critical data on adverse events and product performance. Provide accurate reporting to regulatory bodies like the FDA and EMA and respond more quickly, even during product recalls, if necessary.

You can also streamline product registrations and compliance reporting, all while supporting product safety by managing critical data such as storage conditions, transportation requirements and handling protocols.

Adapt to the evolving needs of your business and the ever-changing regulatory landscape. Have a solution that scales alongside your organization, ensuring that your pharmaceutical, medical device and biotech data management practices stay robust and adaptable to new regulations, emerging technologies or business growth.

Whether you are expanding into new markets, launching new products or navigating complex compliance frameworks, always be flexible and able to manage data effectively.

You can easily configure our MDM solution to meet your specific R&D and clinical operation needs, add new functionalities as required and integrate with other systems as your business grows.