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Maxiom Group led a pharmaceutical client through a Third Party Logistics (3PL) Selection process to find the best service provider for their Phase 2 drug with the following functional areas being the focus:
1. Warehousing, Distribution and Order Fulfillment
2. Financial Services
3. Technology
4. Program Management
5. Quality Systems and Processes
Attributes and capabilities of relevant service providers were assessed, while identifying how they could fulfill our client’s requirements.
The FDA is increasingly asking drug companies to submit, and comply with, a Risk Evaluation and Mitigation Strategy (REMS) as a condition of product approval. REMS is defined by the FDA as a “strategy to manage a known or potential serious risk associated with a drug or biological product.” The components of a REMS program can include:
• Medication guides or communication plans to communicate proper dosing and risks
• Elements to assure safe use or distribution
• Implementation systems to limit the distribution channels, the settings of care or to condition usage based on evidence of safe-use conditions or test results
