Global clinical research organization Veristat is ramping up its regulatory and clinical trial support for pharmaceutical and medical device companies seeking faster entry into major Western markets, as a wave of drug innovation from China accelerates global expansion plans.
The U.S.-based CRO announced expanded services designed to help companies navigate complex regulatory pathways in Europe, the United Kingdom, Switzerland, Australia, Canada, and the United States—markets where regulatory hurdles can slow or block international product launches.
The expansion builds on Veristat’s work helping Chinese pharmaceutical firms such as Hansoh Pharma and CStone Pharmaceuticals secure approvals abroad by guiding them through complex regulatory and legal frameworks. Now the company is widening its scope to deliver full regional clinical trial support alongside regulatory strategy.
China, already the world’s second-largest drug producer, has historically focused on domestic markets. But that is rapidly changing. Nearly half of all new drug molecules currently in human trials worldwide now originate from China.
Analysts at Morgan Stanley project that annual revenue from Chinese-originated drugs could reach $34 billion by 2030 and soar to $220 billion by 2040, as policy reforms encourage international licensing and commercialization.
Before that surge can fully materialize, however, Chinese companies must navigate unfamiliar regulatory landscapes and, in some cases, conduct additional clinical development to meet foreign requirements.
Veristat is positioning itself as a bridge for those companies. The CRO helps drug and device makers move therapies already approved domestically through regulatory pathways abroad, preparing and submitting Marketing Authorization Applications (MAAs) and New Drug Applications (NDAs)—often relying heavily on existing foreign clinical data.
The company can also act as the formal applicant in regions where overseas firms lack a legal presence, allowing regulatory dossiers to be submitted quickly and efficiently.
“Veristat has the deep understanding of the regulatory landscape needed to support foreign organizations with entry to key markets. Our team really enjoyed working with the Veristat team, as they always supported with prompt responses, flexibility, and recommendations on problem-solving,” said Li Zhang, Regulatory Affairs at CStone Pharmaceuticals.
Daphne Smyth, Vice President of Global Regulatory Affairs at Veristat, said: “We also support subsequent submissions in Canada, Switzerland, Australia, and other regions globally, and provide comprehensive assistance throughout the entire agency review process.”
