ISMaPP Competitors

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com

AscellaHealth is a global Specialty Pharmacy and Healthcare services organization serving payers, providers, life sciences and patients, offering a comprehensive portfolio of customized, tech-enabled specialty pharmaceutical and medical management services. AscellaHealth’s unique, patient-centric approach is built upon proprietary technology processes for innovative programs and services optimizing health outcomes and quality of life for patients with complex, chronic conditions or rare diseases that require specialty medications and/or gene and cell therapies. Our end-to-end specialty pharmacy services support all specialty disease states and include, Pre-Commercialization and Market Access Solutions, Hub and Patient Support, Limited Distribution Drug Strategies, Proprietary Specialty Pharmacy and Infusion Network, Customized Clinical Programs, Technology-based Patient Engagement, Medical and Pharmacy Benefit Management, Drug Rebate Programs, and Real-Time Prescription Data and Analytics via our proprietary technology platform. AscellaHealth is at the forefront of the Specialty Pharmacy industry and has proactively developed a customizable suite of services and programs based on shifting trends and market conditions within the specialty pharmacy industry. We are your premier partner in Specialty Pharmacy and Healthcare solutions for improving access, optimizing outcomes, and enhancing the patient journey.

ABOUT Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices. In the three decades since its founding, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market in the US. Our team of regulatory scientists, FDA consultants, and professional services staff has decades of industry and FDA experience that allows us to provide an unparalleled insider perspective for our clients. OUR DIFFERENCE The Biologics Consulting difference is all about the unique combination of regulatory expertise we have under one roof. Our team has depth of knowledge and breadth of experience across all product types and development pathways. This value proposition allows us to address the full scope of a client’s regulatory and product development challenges from preapproval to commercialization. OUR EXPERIENCE AREAS - Biologics - Medical Devices - Pharmaceuticals - Biosimilars OUR SERVICES - CONSULTING – Regulatory, Product Development, Clinical Planning and Quality support. - SUPPORT SERVICES – Medical Writing, e-Publishing & Submissions, US Agent Services, Due Diligence OUR CLIENTS Our clients span the industry, from established multi-national pharmaceutical, biotechnology, and medical device companies to academic and research institutions. We also support small biotech and medical device start-ups. Since our founding, we have professionally services over 4,500 clients from 58 different countries.