Veristat to Acquire Certara's Regulatory and Medical Writing Business in Expansion of CRO Capabilities

Veristat has announced its intended acquisition of Certara's Regulatory and Medical Writing business, a move that will add more than 200 industry experts to the full-service CRO's regulatory affairs and medical writing operations.¹

The transaction is expected to close during the second quarter of 2026, with both companies continuing to operate independently until that time.

The acquired team brings experience authoring clinical and nonclinical documents across the drug development lifecycle, a capability Veristat says will complement its existing strengths in biostatistics, regulatory affairs, and submission strategy. The acquisition is backed by WindRose Health Investors, the New York-based healthcare private equity firm that has supported Veristat's growth strategy.

"By combining our complementary strengths and talented teams, Veristat will have unmatched capabilities in biostats, medical writing, and regulatory affairs," said Kim Boericke, chief executive officer of Veristat, in a company press release. "We will be able to bring even more life-changing medical therapies to patients with unmet needs."

The deal reflects a broader consolidation trend in regulatory services, where sponsors increasingly look to partner with organizations that can manage the full arc of submission preparation without handoffs across multiple vendors.

Exclusive regulatory insight from both organizations

Applied Clinical Trials has spoken with regulatory experts from both companies within the past year, offering a closer look at the depth of knowledge that will come together through this acquisition.

On the Veristat side, John Kirk, principal regulatory strategist, discussed the operational demands of the FDA's Commissioner's National Priority Voucher Program, which grants eligible sponsors a one-to-two-month review timeline in exchange for meeting critical national health needs. The program places significant strain on cross-functional teams, requiring biostatistics, regulatory, and medical writing to function as a single integrated unit rather than sequential handoffs.²

"At Veristat, we have faced 24-hour turnarounds to FDA queries—and success always depends on our regulatory, biostatistics, and medical writing teams seamlessly functioning as a single unit," Kirk said. "The ability to provide comprehensive responses quickly often comes down to having established workflows where team members already understand each other's processes and can mobilize fast."

Kirk also emphasized the importance of early-phase strategic decisions for sponsors pursuing accelerated approval pathways, noting that choices made during initial protocol design can significantly affect the viability of an accelerated pathway years later.

Veristat has supported multiple guidance meetings with the FDA on accelerated approval, including attending Type C meetings alongside sponsors to provide real-time strategic input.

"Early planning and close partnership between the sponsor and CRO are critical to success," he said. "Having experienced team members who understand both the scientific nuances and regulatory expectations—and who can think quickly during these discussions—helps sponsors maximize the value of these limited FDA interactions."

Certara perspective on FDA advancing Bayesian methods

From the Certara side, David Morton, PhD, director of biostatistics, offered perspective on how the FDA's increasing openness to Bayesian statistical methods is reshaping trial design and regulatory strategy.

In a recent video interview with ACT, Morton described a broader shift underway in how sponsors approach evidence generation.

"We're moving a little bit beyond being purely frequentist," Morton said. "There's going to be a lot of innovative approaches becoming more regulatory acceptable from the FDA."

He highlighted external data borrowing—leveraging existing data from previous trials or external controls to reduce sample size requirements—as one of the more operationally significant applications of Bayesian methods, particularly in rare disease and small population studies.

Morton noted that the FDA's clearer guidance on Bayesian approaches is expected to reduce regulatory uncertainty and encourage sponsors to consider these designs earlier, during initial study planning rather than as a late-stage correction.

These perspectives from Kirk and Morton point to a regulatory services landscape that increasingly rewards integration of functions, data sources, and strategic thinking across the development lifecycle.

That integration is precisely what Veristat says it is building toward through this acquisition.

References

1. Veristat to Acquire Certara’s Regulatory and Medical Writing Business. News release. Veristat. April 22, 2026. Accessed April 24, 2026. https://www.businesswire.com/news/home/20260422264798/en/Veristat-to-Acquire-Certaras-Regulatory-and-Medical-Writing-Business

2. FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies. Applied Clinical Trials. June 18, 2025. Accessed April 24, 2026. https://www.appliedclinicaltrialsonline.com/view/fda-national-priority-voucher-program