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 [...]

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 [...]

DSCSA Implementation & Readiness Efforts for 2023

By |2023-03-21T11:13:11-04:0003/20/2023|

DSCSA Implementation & Readiness Efforts for 2023 2023 is a crucial year for pharmaceutical trading partners as the Drug Supply Chain Security Act (DSCSA) deadline for full traceability approaches in November. To allow supply chain stakeholders an opportunity to share their perspectives, the FDA held a 2-day virtual public meeting. DSCSA Implementation [...]

Event Recap: What CMC & Finance Leaders Need to Know about Maintaining Alignment on CMC Programs

By |2023-07-07T11:38:00-04:0002/28/2023|

Event Recap: What CMC & Finance Leaders Need to Know about Maintaining Alignment on CMC Programs CMC and Finance in emerging biotech companies are important partners, but they often find themselves at odds with one another. Complex CMC programs are dynamic, often changing substantially, and require large investments. Similarly, the financing environment in [...]

Traps to Avoid When Preparing for Commercial Launch

By |2023-04-17T10:39:49-04:0002/23/2023|

April 6 @ 6-8p Eastern | Boston Marriott Cambridge Traps to Avoid When Preparing for Commercial Launch Preparing for commercial launch is a big deal for most companies. It requires strong leadership and coordination across many functional areas. There are also technical and regulatory hurdles. The company is investing significant efforts and [...]

Commercial Launch Planning on an Accelerated Timeline

By |2024-02-06T10:20:01-05:0002/13/2023|

Commercial Launch Planning on an Accelerated Timeline PDF Version An emerging European biotech company was preparing to commercially launch its first product in the US. The FDA granted the innovative product a priority review given the potential for significant benefit to patients. As a result, the company faced a compressed timeline to [...]

Minimizing COI & COC Risk

By |2023-02-07T13:24:28-05:0002/07/2023|

Minimizing COI & COC Risk 3 Essential Components for Autologous Cell Therapy Facilities Originally Published as a MassBio Guest Blog Autologous cell therapies involve collecting and processing a patient’s own cells, and later administering the processed cells back into the body to treat the same patient. The personalized nature of these [...]

What Commercial Companies Need to Know about S&OP

By |2024-02-06T14:12:14-05:0011/09/2022|

What Commercial Companies Need to Know about S&OP Sales and Operations Planning (S&OP) is an iterative planning process. It ensures cross-functional alignment on sales forecast and performance, as well as manufacturing forecast and performance. It also provides visibility into forecasted demand and an accurate view of volumes for inventory and production. With this [...]

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