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
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
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…
Supply Chain Services
Each stage of a company’s lifecycle has its own set of Supply Chain challenges – regulatory requirements, clinical and commercial…
Extending Your Quality Capabilities
Focusing on patients and improved outcomes in a rapidly evolving environment requires maintaining appropriate controls to ensure quality and compliance…
CMC Expertise
Development of advanced therapies requires innovative manufacturing and process engineering. CMC (Chemistry, Manufacturing, and Controls) activities expand, evolve, and refocus…