Veristat acquires Catalyst Regulatory Services

Contract research organization Veristat announced today that it completed the acquisition of Catalyst Regulatory Services, a company that provides regulatory support to biopharmaceutical firms, for an undisclosed amount.

Southborough, Mass.-based Veristat said Catalyst’s combination of experience and expertise in the regulatory space will help the company implement strategies, applications, submissions and interactions with regulatory agencies around the world.

“With the addition of Catalyst, Veristat has amassed a superior team of regulatory experts to offer strategic and operational regulatory support throughout all phases of drug, biologic, and medical device development,” Veristat CEO Patrick Flanagan said in a news release. “We continue to expand and strengthen our regulatory offering to support the growing demand for our experience and insights with regulators. Our regulatory solutions make an impact — in 2018 alone — Veristat teams prepared marketing applications for 12% of new molecular entities (NMEs) approved by the FDA.”

Veristat also announced that it appointed former Catalyst president Mark Ammann to the role of SVP, regulatory affairs at the company. Ammann has more than 25 years of experience in pharmaceuticals and service organizations, according to a news release.

“We are excited to join the Veristat team,” Ammann said. “The combination of Catalyst Regulatory Services and Veristat creates a diverse regulatory talent pool that can provide comprehensive regulatory support including regulatory CMC, labeling, advertising/promotion, and FDA meeting preparation and agency engagement. Together, we support a wide range of products, from traditional small molecules and simple biologics to combination products, as well as more complex approaches including antibody-drug complexes, and cellular and gene therapies.”