What Emerging Companies Need to Know about PAI Readiness

By |2024-04-24T16:37:42-04:0004/25/2024|

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 [...]

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 [...]

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 [...]

Navigating Stage-Appropriate Quality System Design

By |2024-02-06T14:06:00-05:0006/29/2023|

Navigating Stage-Appropriate Quality System Design Originally Published as a MassBio Guest Blog Our emerging biotech and biopharma clients often request support from our skilled consultants and practitioners to develop a “Stage-Appropriate cGMP Quality System." However, we find that they are often not fully aware of what “stage-appropriate” means or what it looks [...]

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 [...]

Event Recap: Supply Chain Planning for Today’s Uncertain World

By |2023-06-28T16:44:42-04:0004/06/2023|

Event Recap: Supply Chain Planning for Today’s Uncertain World Contributors: Supply Chain Director Jeremy Friedler, Supply Chain Consultant Sean Carroll & Intern Ryan Chapados Uncertainty and risk have been consistent themes inherent to biopharmaceutical supply chains. The recent pandemic has only amplified this notion. Since the pandemic started, many emerging companies [...]

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