Veristat, a global clinical research organization (CRO) and regulatory consultancy, has expanded its regulatory and clinical trial support services to help international pharmaceutical and medical device companies navigate approvals in key global markets, including the United Kingdom, Switzerland, Australia, Canada and the United States.

The expanded services are designed to provide a streamlined pathway for companies seeking to commercialise therapies beyond their domestic markets. Veristat has previously supported several Chinese pharmaceutical firms, including Hansoh Pharma and CStone Pharmaceuticals, in navigating regulatory requirements and achieving product approvals in multiple regions.

China has emerged as the world’s second-largest drug producer and is increasingly becoming a major source of new drug candidates. Nearly half of all new drug molecules currently undergoing human trials globally originate from China, reflecting the country’s growing influence in pharmaceutical innovation.

To support this shift, Veristat offers regulatory expertise to help Chinese drug and device developers advance therapies already approved domestically through international regulatory pathways. The company assists with preparing and submitting Marketing Authorization Applications (MAAs) and New Drug Applications (NDAs), often leveraging foreign clinical data.

The CRO also conducts gap analyses of clinical and regulatory data packages to identify additional requirements for global submissions. Where necessary, Veristat provides clinical trial execution support to generate supplementary data needed for approvals in different regions.

According to the company, it has recently supported multiple regulatory approvals across the United States, Europe and the United Kingdom through comprehensive dossier preparation and engagement with regulatory agencies such as the US Food and Drug Administration, European Medicines Agency and Medicines and Healthcare products Regulatory Agency.

Between 2020 and 2025, Veristat submitted 68 initial investigational new drug and drug master file applications, along with several marketing applications to regulatory authorities in the US and Europe.

With more than three decades of experience and involvement in over 100 regulatory approvals, the company provides integrated services spanning regulatory strategy, clinical development and trial execution across therapeutic areas including rare diseases, oncology, neurology and advanced therapies such as cell and gene treatments.