Veristat has agreed to acquire Certara’s regulatory and medical writing business in a move that expands its clinical development and submission capabilities across drug development programmes.

The CRO said the transaction will add more than 200 regulatory and medical writing specialists to its organisation, strengthening its ability to support clinical trial sponsors through regulatory submissions and associated documentation across complex therapeutic areas.

The business being acquired is focused on authoring clinical and non-clinical documents used throughout the drug development lifecycle, including regulatory filings that support submissions to health authorities.

Veristat said the deal is intended to enhance its existing services across biostatistics, regulatory affairs and medical writing, creating a broader offering for pharmaceutical and biotech customers running late-stage clinical programmes.

Kim Boericke, chief executive officer of Veristat, said: “By combining our complementary strengths and talented teams, Veristat will have expanded capabilities in biostats, medical writing, and regulatory affairs, supported by science-based insights and client partnerships.”

The company described the acquisition as part of a broader strategy to scale its support for complex clinical development programmes, particularly in areas requiring specialist regulatory expertise and integrated submission support.

Regulatory writing and submission preparation remain key bottlenecks in late-stage drug development, where timelines can be influenced by documentation quality, consistency and regulatory alignment. Demand for outsourced expertise in this area has grown as clinical pipelines become more complex and global submissions increase in scope.

The acquisition is backed by WindRose Health Investors, which continues to support Veristat’s expansion strategy in the clinical research services sector.

The transaction is expected to close in the second quarter of 2026. Until completion, Veristat and Certara’s regulatory and medical writing business will continue to operate independently.

Certara has not disclosed financial terms or any restructuring impact associated with the carve-out.

The deal adds to ongoing consolidation across the contract research organisation (CRO) and regulatory services market, where companies are increasingly seeking to bundle capabilities across clinical development, data management and submission support.

For Veristat, the acquisition increases its scale in a competitive outsourcing market where sponsors are under pressure to accelerate trial timelines while maintaining regulatory compliance across multiple jurisdictions.