Veristat, Inc., a full-service CRO, announced today that it has completed the acquisition of Catalyst Regulatory Services, LLC., a US-based regulatory services company. Catalyst provides comprehensive regulatory support to biopharmaceutical firms as they obtain and maintain their regulatory applications along the pathway to market approval.
“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,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “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.”
Helping sponsors develop and pursue the right regulatory pathway for their clinical program requires years of experience, expertise with agency interactions and a proven history of success. That is why Veristat acquired Catalyst Regulatory Services. This combination creates a unique and unmatched team of senior regulatory experts who develop and implement regulatory strategies, applications, submissions, and interactions with regulatory agencies around the globe.
As part of the acquisition, Veristat appoints Mark Ammann, Pharm.D., former President of Catalyst Regulatory Services, LLC., to the role of Senior Vice President, Regulatory Affairs, where he will lead the regulatory affairs team. Mark is a recognized leader in the regulatory affairs community with extensive knowledge of regulatory challenges throughout the clinical development process. His 25+ years of experience include positions in both Big Pharma and service organizations. The therapeutic expertise of Mark and the broader Catalyst team augment and expand the oncology, rare disease, neurological and anti-infection depth of Veristat today by increasing our experience in numerous therapy areas including Cardiovascular Disease, Psychiatry, Neurology, Diabetes, Metabolic Disorders, Inflammation, Oncology, Dermatology, and Nephrology.
Want to publish your own articles on DistilINFO Publications?
Send us an email, we will get in touch with you.
“We are excited to join the Veristat team,” said, Mark Ammann, Pharm.D., now Senior Vice President, Regulatory Affairs at Veristat, “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.”
Source: BioSpace
