Designing High Quality CMC Regulatory Submissions – A Systematic Approach
By Jason Birri, Associate Principal Consultant
Microbiome Therapies Beyond Fecal Microbiota Transplantation (FMT) – Challenges and Opportunities
By Anmol Grover, Senior Consultant, Strategy and Program Leadership
Resumption of FDA Inspections: What’s Next?
By Alessandra Baffa, Consultant & Liz Bodi, Asoociate Principal Consultant
5 Key Elements of Resilient Systems: Where Life Sciences and Homeland Security Intersect
“How an institution responds to a variety of crises…is one of the most challenging and consequential aspects of leadership. Understanding what a crisis is, when you are in it, and what skills are needed to manage through it is an essential skill for government and private sector leaders. To