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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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