Oracle PLM for the Pharmaceutical and Biotechnology Industries

With profound innovations, regulatory fluctuations, fierce competition, and a changing healthcare landscape, few industries have seen such disruption as pharmaceuticals and biotechnology. Now is the time to strengthen your product development processes with disciplined best practices to achieve competitive differentiation and profitability.

Oracle Product Lifecycle Management (PLM) offers a holistic approach to centralize, improve, and manage product data and processes across the enterprise—including R&D, quality, production, regulatory assurance, and marketing. With modern PLM processes, you can simplify the highly complex drug development process, better manage clinical trial inventories, and close gaps between R&D and corporate strategy.

• Drug Development Portfolio Management
  Integrate project schedule and resources management with evidence creation.
• Combination Drug/Device Product Development
  Synchronize the design and computer analysis of the combined development process with an enterprise compliant product record to improve regulatory integrity.
• Structured Electronic Drug Development Record (eDDR)
  Automate lab development archive and design dossier management.
• Integrated Clinical Supply Development and Management
  Improve contract manufacturing organization (CMO) collaboration and material chain-of-custody management.
• Technology Transfer and Collaboration
  Enable secure collaboration both internally and externally with evidence archive and knowledge re-use.
• Integrated Quality and Risk Management
  Ensure compliance and quality from innovation to development to commercialization to enable quality by design (QbD).
• Comprehensive Packaging and Collateral Management
  Synchronize packaging, labeling, and collateral content with registration.
• Global Product Registration
  Automate product registration, strategy, submittal creation, electronic common technical document (eCTD) management, and dossier management.