Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline

By |2024-06-03T12:37:10-04:0005/22/2024|

Webinar on June 20 @ 12-1p ET Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline Join us for a webinar with experts on navigating serialization compliance and beyond. Discussion will range from the most critical aspects of the new requirements to best practices for dealing with requests and exceptions. You will [...]

Managing a Tech Transfer Redesign Post-Acquisition

By |2024-01-29T11:02:22-05:0001/29/2024|

Managing a Tech Transfer Redesign Post-Acquisition Managing a Technology Transfer (TT) is often complex, and redesigning an existing TT process even more so. Companies will generally redesign their TT processes to accommodate changes in technology, regulatory requirements, clinical strategies, or other similar reasons. However, even repurposing a manufacturing facility can drive a [...]

Life After DSCSA Compliance

By |2023-11-20T10:08:41-05:0011/20/2023|

Life After DSCSA Compliance In September, the FDA provided the pharmaceutical industry with a 12-month extension to the Drug Supply Chain Security Act (DSCSA). The FDA states that this “stabilization period” is for the industry to finetune their systems and processes. However, it’s also abundantly clear that the DSCSA compliance deadline remains November [...]

Event Recap: Digitization of the Supply Planning Process

By |2024-02-06T13:51:53-05:0011/03/2023|

Event Recap: Digitization of the Supply Planning Process Many emerging and mid-sized biopharma companies work to digitize their supply planning process as they grow, as part of larger efforts to digitally transform and automate manual processes. In Converge Consulting’s ongoing work with clients, we have seen a distinctive gap for these companies: planning [...]

Converge Perspective on the FDA Delayed Enforcement

By |2023-09-07T11:02:48-04:0009/07/2023|

Converge Perspective on the FDA Delayed Enforcement Originally published on the MassBio News & Thought Leadership blog On June 2, 2023, the Healthcare Distribution Alliance (HDA) submitted to the Federal Drug Administration (FDA) a letter outlining challenges for implementing the last mile of DSCSA compliance. Chief among these is manufacturers’ inability to [...]

Info Sheet: Global Logistics & Trade Compliance Services

By |2024-02-06T14:50:52-05:0005/23/2023|

Global Logistics & Trade Compliance Services Info Sheet Download PDF Supply chains are growing in complexity whether they support preclinical, clinical, or commercial companies. Biopharma companies work with a global network of suppliers, labs, and contractors, all while the industry continues experiencing after-effects of pandemic-related restrictions and disruptions. The need to manage [...]

ERP Implementations: Understanding Technical Versus Business Go-Live

By |2023-08-14T09:49:08-04:0004/27/2023|

ERP Implementations: Understanding Technical Versus Business Go-Live Many life science companies rely on enterprise resource planning (ERP) to help manage and integrate essential parts of the business. Implementing an ERP solution is a major undertaking for any organization. Even when the right ERP option is selected, implementation must consider the needs of [...]

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