From China partnerships to Western clinical development

Verta has supported four partnerships between U.S. sponsors and Chinese biotech companies, helping clients navigate the scientific, regulatory, and operational complexities involved in bringing these molecules into Western clinical development.

Starting with comprehensive due diligence

Our work begins with comprehensive due diligence. We partner with clients to evaluate critical Chemistry, Manufacturing, and Controls (CMC) components, including cell line development, manufacturing processes, analytical methods, stability data, and supply chains. This detailed assessment helps identify potential risks and gaps that must be addressed before a product can be advanced into clinical trials in the U.S. and EU.

Building submission-ready documentation

Building on this foundation, Verta leverages data provided by the originating Chinese companies to prepare high-quality regulatory documentation. This includes authoring Module 3 sections and Overall Quality Summaries (QOS).

The work is not simply translation. It is the conversion of technical evidence into a regulatory story that Western agencies can review efficiently and trust.

Bridging two systems

With deep expertise and Chinese-speaking regulatory and quality consultants, Verta is positioned to bridge the gap between U.S. and Chinese biotech companies. Whether supporting inbound licensing or enabling global clinical development, we help clients move forward with confidence.

For organizations exploring opportunities to acquire or develop China-originated molecules, contact Verta to discuss how we can support your program.