Veristat, a global clinical research organization and consultancy specializing in complex medical studies, has announced the expansion of its regulatory and clinical trial services aimed at pharmaceutical and medical device companies seeking access to major international markets. The expanded offering is particularly focused on supporting organizations from China that are looking to introduce their products in Europe, the United Kingdom, Switzerland, Canada, Australia, and the United States.
Veristat has already worked with several Chinese life sciences companies—including Hansoh Pharma and CStone Pharmaceuticals—to help them navigate regulatory procedures and secure approvals for new therapies outside their domestic market. Building on this experience, the company will now provide broader clinical trial execution and regulatory support designed to simplify the process of entering these highly regulated regions.
China has become a major contributor to global drug development. It is currently the world’s second-largest pharmaceutical producer and an increasing number of innovative medicines are originating from the country. Nearly half of all new drug molecules currently undergoing human clinical trials worldwide are believed to come from Chinese developers. Financial analysts also expect international revenue from China-developed drugs to grow substantially in the coming decades, reflecting the rising influence of the country’s life sciences sector.
Despite this momentum, companies seeking to commercialize treatments abroad must navigate complex regulatory frameworks and meet strict clinical evidence requirements. Veristat aims to bridge this gap by offering specialized regulatory guidance and clinical development services tailored to international approval processes.
The organization provides support for preparing and submitting key regulatory applications such as Marketing Authorization Applications (MAA) and New Drug Applications (NDA). In many cases, these submissions rely heavily on clinical data generated outside the target markets. Veristat’s regulatory specialists assist companies in ensuring that this data meets the standards required by regulatory agencies across multiple jurisdictions.
For organizations that do not have a legal presence in regions such as Europe or North America, Veristat can also serve as the official applicant for regulatory submissions. This capability allows companies to move forward with product approvals without needing to establish local entities, reducing both time and operational complexity.
Veristat’s multidisciplinary team begins each project by conducting a detailed assessment of the client’s existing data package. This evaluation identifies any gaps that may prevent regulatory approval and outlines the most efficient strategy for addressing them. The team then works closely with the sponsor to generate additional analyses or data where necessary and to compile a complete regulatory submission for the relevant authorities.
In cases where clinical trial data from the company’s home country does not fully meet international standards, Veristat also provides end-to-end clinical trial support. This includes study planning, trial management, and data analysis to ensure that all regulatory requirements are satisfied.
According to Veristat’s regulatory leadership, the company has recently achieved multiple approvals for Chinese clients in the United States, the European Union, and the United Kingdom. These successes involved the development of comprehensive regulatory dossiers and direct engagement with agencies such as the European Medicines Agency, the UK’s Medicines and Healthcare products Regulatory Agency, and the U.S. Food and Drug Administration.
Between 2020 and 2025, Veristat submitted dozens of regulatory filings, including 68 initial Investigational New Drug applications and Drug Master Files, along with several marketing authorization submissions across major regulatory regions.
With more than three decades of experience in supporting clinical development programs, Veristat has contributed to over 100 regulatory approvals worldwide. The company’s expertise spans several therapeutic areas, including rare diseases, neurology, oncology, and advanced therapies such as gene and cell-based treatments. By expanding its services for international life sciences companies—particularly those from China—Veristat aims to accelerate the availability of innovative treatments for patients around the world while helping drug and device developers successfully navigate the complexities of global regulatory pathways.
