White Papers
Practical notes on CMC strategy, regulatory interactions, and manufacturing partnerships — from the team at Verta Life Sciences.
Acquiring rights to an innovative asset is only the beginning. Here are the CMC, regulatory, and operational considerations that can determine how smoothly it moves into U.S. and EU development.
Five practical questions to help sponsors build a right-sized Quality Management System from early R&D through commercial supply.
How Verta combines in-country China QA expertise with global FDA and EMA expectations to help sponsors maintain inspection-ready supply chains.
How Verta helps U.S. sponsors evaluate China-originated molecules, prepare CMC documentation, and move programs into Western clinical development.
How Verta led the entire CMC program for a monoclonal antibody COVID treatment, rapidly scaling up and managing 7 CDMOs simultaneously.
How Verta supports China due diligence for U.S. and EU sponsors - evaluating CMC components, preparing regulatory documentation, and advancing molecules into Western clinical trials.
A closer look at raw material sourcing, qualification, and change control — and why gaps here surface at the worst possible time.
How sponsors align validation depth with clinical stage — and where programs often fall short before commercial readiness.
A practical look at CMC-related questions, completeness, and how teams prepare for the final stretch of review.
What to verify beyond the site tour — quality systems, governance, and tech transfer readiness.