HomeQuality & RegulatorySupply ExcellenceEnsuring Security of Supply for Biopharmaceutical Manufacturing

Ensuring Security of Supply for Biopharmaceutical Manufacturing

In a rapidly changing and dynamic world, you need a supplier focused on robustness, resiliency, and transforming their supply chain to meet the changing needs of the Biopharmaceutical industry. Today’s Biopharmaceutical manufacturers need not only supply security, but suppliers who will partner with them to navigate changing regulations and the development of sustainable business operations.

Today's complex and global supply chains require an end-to-end focus on risk management and planning to ensure agile business continuity.

Our multi-faceted and global approach includes:

  • Business Continuity Planning and Disaster Recovery Planning
  • Supplier Risk Management
  • Supply Chain Mapping

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To ensure continuity of supply and to mitigate risk against disruptions, we continuously invest in improving the agility of supply network.

In-region for-region manufacturing backed by a global network of redundant manufacturing centers improves network agility and ensures business continuity. Globally harmonized manufacturing and quality governance standards ensures consistent performance.

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Our quality and regulatory programs are grounded in our extensive industry experience and aligned with industry best practices. Our over 1700 global quality and regulatory professionals ensure compliance and quality for all our live science products.

Simplify regulatory approvals and de-risk process development with informed decisions on key components and raw materials that are fit for purpose and compliant with quality and regulatory standards.

Emprove® Program provides Dossiers covering Material Qualification, quality management, and operational excellence to support regulatory submissions and compliance.

M-Clarity™ Program defines product quality levels and transparency to quality documentation and change notification supported for the majority of our life science products.

Change Notification Program based on validated change control processes and our M-Clarity program.

Dedicated global quality and regulatory teams provide regional market surveillance and support for regulatory changes and challenges.

Regulatory Expertise and support for Pharmaceutical and Biopharmaceutical manufacturers.

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Our commitment to sustainability is embedded in our values and our corporate strategy. We take a holistic life-cycle approach to sustainability that is closely tied to our ethical standards. Our global regulatory team, in close collaboration with our Supply Chain organization, is developing greener products for the biopharmaceutical industry and collaborating with our customers to ensure they navigate the changing regulations and the transition to a sustainable supply chain.

Our programs include:

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Leveraging digitalization in the supply chain is key to accelerating innovations in Bioprocessing, improving manufacturing processes, and increasing supply chain agility.

The eMERGE™ Program, our standardized platform solution for the exchange of data, is compatible with existing Process Monitoring and Analytics systems, including our Bio4C™ Process Pad.

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