As the world-wide healthcare industry grows and changes, pharmaceutical contract manufacturing organizations (CMOs) play an increasingly important role in improving the efficiency of the drug supply chain and making key contributions to patient well-being. They also occupy a complicated spot in that supply chain, interacting with a wide variety of partners and customers, from manufacturers to 3PLs. Manufacturers are held liable by the FDA for serialized drug products, and CMO serialization responsibilities are critical to the overall DSCSA compliance.
LSPEDIA CMO MANAGEMENT
Working with LSPediA means you have a partner with deep experience and a complete understanding of on-boarding CMOs into the serialization process, including:
- CMO Quality Agreement: Issuing CMO quality agreements to hold CMOs responsible and accountable for serialization
- Serialization specification: Issuing serialization specifications to guide CMOs through the process
- CMO Serialized Data Exchange: Establishing new technology and automate touchpoints to allow serialized data exchange
- Assess CMO Readiness: Assessing serialization gaps and taking action to mitigate risks
- Manage CMO Deliverables: Ensuring CMOs stick to agreed-upon deadlines and responsibilities
- Improve CMO Efficiency: Providing optimized packaging, QA, and warehouse processes for you and your CMOs
The benefits you gain by partnering with us go beyond implementing serialization. LSPediA will extend process improvements across your organization to:
- Lower overall serialization spending by reducing the number of redesigns
- Mitigate compliance risks with comprehensive, gapless coverage tailored to your specific needs
- Shorten your project timeline by removing the trial-and-error process
Contact us today and we’ll create a serialization strategy that’s right for your manufacturing business, and tailored to your CMO partnerships.
LSPediA’s leadership has been awesome. Their project management skills have been terrific. The expertise and knowledge around manufacturing, regulations, serialization, and integrating systems has been incredibly valuable to us.”
A Pharma Customer
I would have no issue recommending LSPediA to be the project leader in the implementation of DSCSA and serialization — or any other technology solution a company is looking to develop. We appreciate what LSPediA has done for us.
A Pharma Customer