Commercial

Perspective

Navigating Tariff Volatility: Strategic Pathways for Emerging Life Sciences Companies

New perspective from Gartner highlights that Chief Supply Chain Officers must plan for long-term volatility, considering potential countermeasures, escalations, and de-escalations.…

Perspective

The Strategic Imperative of Supplier Risk Management for Biopharmaceuticals

In recent years, the biopharmaceutical industry has faced an increasingly complex and volatile supply chain risk landscape. The lasting effects…

Perspective

The BIOSECURE Act: Safeguarding U.S. Biotechnology

The BIOSECURE Act is a pivotal U.S. legislative measure designed to safeguard national security by restricting federal contracts and funding…

Perspective

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Avoiding Approval Risks at Your CMO Facility

In August 2024, Regeneron received a Complete Response Letter (CRL) from the FDA for its multiple myeloma treatment candidate. The…

Perspective

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Event Recap: TraceLink FutureLink Barcelona Conference 2024

TraceLink recently hosted FutureLink Barcelona 2024, their annual European meeting for supply chain participants. Since Europe enacted serialization requirements back…

Perspective

Rightsizing a Business Continuity Program

Many emerging biopharmaceutical companies neglect to develop business continuity plans because they are operating with constrained resources. Even with the…

Perspective

The Evolving Ecosystem for Biopharma Manufacturing

A significant – even seismic – shift is taking place in biopharma manufacturing and technical operations right now. It is…

Perspective

US-China Trade Tension: Increasing Uncertainty for Biopharma

In recent years, the US government has increasingly leveraged trade policy as a tool for broader U.S. foreign policy. This…

Perspective

Highlights from Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline Webinar

2024 is a crucial year for the life science industry. November marks the end of the DSCSA stabilization period and…

Perspective

Impact of Rejecting Chevron Deference on Biopharma

On June 28, the Supreme Court of the United States (SCOTUS) overruled the most cited legal case in its history, colloquially…

Perspective

Event Recap: FutureLink 2024

At the end of May 2024, TraceLink hosted its annual conference – FutureLink 2024. The event brings together manufacturers, brand…

Perspective

Drafting SOPs for a Facility that Does Not Exist Yet

When a biopharma company is bringing up a new manufacturing or warehouse facility, there are many standard operating processes/procedures (SOPs)…

Perspective

Last Mile Logistics: How Manufacturers Can Help Ensure Product Integrity for Patients

Last mile logistics, the final leg of the supply chain from distribution centers or pharmacies to the point of administration,…

Perspective

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…

Perspective

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…

Perspective

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…

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Converge Consulting exclusively serves the Life Sciences industry with strategy, operations, and execution expertise. We are based in the Boston/Cambridge area, one of the most active hubs for Life Sciences best practices in the world.