Veristat Broadens CRO Services to Support Chinese Biopharma Market Entry in Europe

• Veristat has expanded its regulatory and clinical trial services to help Chinese pharmaceutical and medical device companies pursue approvals in Europe and other international markets.

• The CRO provides regulatory strategy, dossier preparation, and clinical trial support to help companies navigate regional requirements and submit marketing applications.

Veristat has expanded its regulatory and clinical services to support Chinese pharmaceutical and medical device companies seeking to enter European markets. The contract research organization (CRO) said the expanded offering aims to provide a streamlined pathway for companies pursuing approvals in Europe, including the United Kingdom and Switzerland, as well as the United States, Canada, and Australia.

The company provides regulatory strategy, dossier preparation, and clinical trial support to companies whose products have already received domestic approval but require additional regulatory work for international markets. Veristat said it can assist with preparing and submitting Marketing Authorization Applications (MAA) and New Drug Applications (NDA), often using foreign clinical data as part of regulatory submissions.

According to the announcement, the CRO can also act as the applicant for companies that do not have a legal presence in certain regions, enabling them to submit regulatory dossiers more efficiently. The company’s services include conducting gap analyses of data packages, identifying additional analyses required for submission, and generating supporting documentation for regulatory agencies.

China’s pharmaceutical industry is increasingly focused on international commercialization. Nearly half of new drug molecules in human trials globally originate from China, and Morgan Stanley projects annual revenue from Chinese-originated drugs could reach $34 billion by 2030 and $220 billion by 2040.

“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.”

Daphne Smyth, Vice President of Global Regulatory Affairs at Veristat.