Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline

By |2024-06-25T16:52:33-04:0005/22/2024|

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 [...]

What Emerging Companies Need to Know about PAI Readiness

By |2024-06-10T13:56:54-04:0004/25/2024|

What Emerging Companies Need to Know about PAI Readiness Originally Published as a MassBio Guest Blog Pre-Approval Inspection (PAI) is a crucial step for emerging companies and ensuring PAI readiness is a vital set of activities for transitioning a drug or therapy from development to market and commercialization. We often see [...]

Essential Elements of Commercial Mock Launch for Emerging Biotech Companies

By |2024-02-19T11:49:20-05:0002/19/2024|

Essential Elements of Commercial Mock Launch for Emerging Biotech Companies Every emerging biotech company has the unique opportunity to establish itself as a reliable partner to patients, physicians, and payers by executing impeccable product launches. As emerging companies gear up for commercial launch, however, it’s common for departments to concentrate on their [...]

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 [...]

ERP Implementations: How to Ensure a Successful Business Go-Live

By |2023-09-19T09:58:20-04:0009/19/2023|

ERP Implementations: How to Ensure a Successful Business Go-Live This series starts with ERP Implementations: Understanding Technical Versus Business Go-Live, which focuses on why it is critical to balance the requirements of both for success. Achieving successful go-lives across both the technical and business dimensions is essential to ensuring a successful Enterprise [...]

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 [...]

Event Recap: Avoiding Common Traps in Commercial Launch

By |2024-04-11T10:52:19-04:0008/21/2023|

Event Recap: Avoiding Common Traps in Commercial Launch The commercial launch of a new drug is a make-or-break moment for a company. It represents the culmination of years of R&D, and the potential for significant benefit to patients, as well as financial gain for the company. Emerging pharmaceutical and biotechnology companies often partner [...]

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