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
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
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,…
Extending Your Quality Capabilities
Focusing on patients and improved outcomes in a rapidly evolving environment requires maintaining appropriate controls to ensure quality and compliance…
Operational Excellence Services
Biopharmaceutical firms face huge challenges as they commercialize their drug discoveries. The level of internal risk is high given daunting…