The Quarter Horse: Issue 22
Issue 22 of the official Dark Horse Consulting Group newsletter.
Perspective
The Quarter Horse: Issue 21
Issue 21 of the official Dark Horse Consulting Group newsletter.
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The Quarter Horse: Issue 20
Issue 20 of the official newsletter of the Dark Horse Consulting Group announced the acquisition of Converge Consulting.
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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…
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The Evolving Ecosystem for Biopharma Manufacturing
A significant – even seismic – shift is taking place in biopharma manufacturing and technical operations right now. It is…
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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…
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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…
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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…
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What Emerging Companies Need to Know about PAI Readiness
Pre-Approval Inspection (PAI) is a crucial step for emerging companies and ensuring PAI readiness is a vital set of activities…
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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…
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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…
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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,…
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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…
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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…
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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 Perspective on the FDA Delayed Enforcement
On June 2, 2023, the Healthcare Distribution Alliance (HDA) submitted to the Federal Drug Administration (FDA) a letter outlining challenges…