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
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
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
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…
Perspective
2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors
Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act…
Perspective
Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022
Per DSCSA, the U.S. pharmaceutical industry must be exchanging EPCIS data at the serialized package level by November 27,…
Perspective
Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements
While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November…
Perspective
5 Unique Logistics Challenges for Specialty Pharmaceuticals
Many of our clients are innovator companies developing novel treatments that are often complex and extremely high value. As a…