SOUTHBOROUGH, MASS. -- Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced expanded regulatory and clinical trial services to international pharmaceutical and medical device companies seeking a streamlined path into European, including the United Kingdom and Switzerland, plus Australian, Canadian, and U.S. markets. Particularly, Veristat has helped many Chinese companies - including Hansoh Pharma and CStone Pharmaceuticals - successfully navigate regional regulatory requirements and legal complexities leading to product approvals. Now, Veristat is expanding to provide comprehensive regional clinical trial support.

China is the world's second-largest drug producer but has traditionally focused on domestic commercialization. Today, that is changing. Nearly half of all new drug molecules in human trials worldwide now originate from China, and Morgan Stanley projects annual revenue from Chinese-originated drugs could reach $34 billion by 2030 and $220 billion by 2040. Due to recent policy changes that open new opportunity for China, it is expected to become a major hub for licensing deals for international commercialization. But before the ‘sleeping giant’ can awaken, it needs regulatory and, sometimes, clinical development support in local markets.

Veristat provides Chinese drug and device companies with trusted regulatory services to bring novel therapies already approved domestically through regional regulatory pathways for approval across Europe, the UK, Switzerland, the US, Canada, and Australia. The American-based CRO has extensive experience preparing, submitting, and obtaining approvals for Marketing Authorization Applications (MAA) and New Drug Applications (NDAs), often based largely on foreign data. Veristat can also serve as the applicant to enable companies without a legal presence in these regions to quickly and efficiently submit their regulatory dossiers.

“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.

Veristat’s multidisciplinary team conducts a thorough Gap Analysis of each customer’s data package, recommends the most efficient regulatory strategy, and guides the best path to approval across countries. This includes identifying and generating any additional analyses required, as well as compiling or developing the necessary data for submission to the relevant agencies. For instance, Veristat offers comprehensive clinical trial execution support for foreign companies whose domestic clinical trial data is not sufficient for local regulatory requirements.

“Veristat has had tremendous success for China-based customers recently, securing approvals in the US, EU, and UK. These successes were achieved through comprehensive dossier development and effective negotiations with EMA, MHRA, and FDA,” explained Daphne Smyth, Vice President of Global Regulatory Affairs at Veristat. “We also support subsequent submissions in Canada, Switzerland, Australia, and other regions globally, and provide comprehensive assistance throughout the entire agency review process.”

Between 2020 and 2025, Veristat submitted 68 initial INDs and DMFs, 10 initial Food and Drug Administration (FDA) marketing applications, and 8 initial EMA/MHRA/Swissmedic marketing applications. With 30 years of supporting more than 100 regulatory approvals, the full-service CRO has deep experience in rare disease, neurological disease, oncology, and advanced medicines including cell and gene therapies.

Veristat will be attending BIO China (March 12-14) and CMAC (March 18-20) both in Suzhou, China, where companies can learn more about its international service offering. Email Lorenzo.scalise@veristat.com to arrange a meeting.