Uitbreiding van het team van regelgevende experts om biofarmaceutische sponsors langs de weg naar marktgoedkeuring te begeleiden
SOUTHBOROUGH, Mass. – (BUSINESS WIRE) – Veristat, een full-service CRO, kondigde vandaag aan dat het de acquisitie heeft voltooid van Catalyst Regulatory Services, LLC., Een in de VS gevestigd regelgevingsbedrijf. Catalyst biedt uitgebreide regelgevende ondersteuning aan biofarmaceutische bedrijven wanneer zij hun regelgevende toepassingen verkrijgen en behouden langs de weg naar goedkeuring van de markt.
“Met de toevoeging van Catalyst heeft Veristat een superieur team van regelgevende experts verzameld om strategische en operationele regelgevende ondersteuning te bieden tijdens alle fasen van de ontwikkeling van geneesmiddelen, biologische en medische hulpmiddelen”, aldus Patrick Flanagan, Chief Executive Officer bij Veristat. “We blijven ons regelgevingsaanbod uitbreiden en versterken om de groeiende vraag naar onze ervaring en inzichten bij regelgevers te ondersteunen. Onze oplossingen voor regelgeving hebben invloed – alleen in 2018 – hebben Veristat-teams marketingtoepassingen voorbereid voor 12% van de New Molecular Entities (NME’s) die zijn goedgekeurd door de FDA. ”
Veristat Strengthens Its Regulatory Expertise with the Acquisition of Catalyst Regulatory Services
Expanding Its Team of Regulatory Experts to Guide Biopharmaceutical Sponsors Along the Pathway to Market Approval
SOUTHBOROUGH, Mass.–(BUSINESS WIRE)– Veristat, 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.
“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.”
Veristat is a scientifically oriented and impactful full-service clinical research organization (CRO) that is committed to partnering with pharmaceutical, biotechnology, and medical device firms to advance their therapies throughout the entire clinical development and regulatory submission process. Veristat helps clients solve the unique and complex challenges that arise when trying to accelerate therapies along the development pathway to successful regulatory approval, beginning with study design, protocol development, site selection, and start-up through to clinical monitoring, data collection, analysis, and reporting. Veristat provides experience-based strategic decision-making, the operational efficiencies to manage and monitor international trials, the biometrics expertise to collect, analyze and report clinical trial data to various regulatory agencies, and the therapeutic and medical proficiency in overseeing the entire process. Ultimately, we guide our clients to market success so that their therapies become available to improve and save people’s lives. In 2018, a record-setting year of FDA approvals Veristat supported the marketing applications for 12% of all FDA NME approvals. For more information, visit http://www.veristat.com.
Gillian Dellacioppa, Marketing Director
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