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
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…
Perspective
Navigating Stage-Appropriate Quality System Design
Our emerging biotech and biopharma clients often request support from our skilled consultants and practitioners to develop a “Stage-Appropriate cGMP Quality…
Perspective
What Commercial Companies Need to Know about S&OP
Sales and Operations Planning (S&OP) is an iterative planning process. It ensures cross-functional alignment on sales forecast and performance, as…
Perspective
Transitioning to Computer Software Assurance from Computer Systems Validation
Life science companies need to verify that GxP computer and software systems accurately support their intended business processes. The traditional…
Perspective
Event Recap: Building High-Touch Patient Supply Chains
The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies…
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…
Perspective
Event Recap: Stage-Appropriate Quality Systems
Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for…