Our goal is to ensure a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. We enable faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. CSSi LifeSciences has successfully supported the development of hundreds of drugs, biologics, devices, and in-vitro diagnostics.
We are uniquely positioned to provide a comprehensive and scalable suite of services to develop therapeutic drugs and devices with cost-efficient predictability. We have the expertise to support lifecycle strategies that drive product value, extend market share, and maximize ROI.
Avoid the “large CRO shuffle” – We offer cost efficient, fully integrated expertise and services from start to finish.
Based on if the product is a drug, biologic or cell-based therapy and current stage of development, there are a variety of submissions that may be required by regulatory agencies in the US, Europe, Canada, and throughout the globe. Utilizing strategies designed to address regulatory concerns and minimize additional questions, our team reviews, prepares and submits documents required for appropriate regulatory pathways.
Our team has prepared and submitted hundreds of successful regulatory documents, including:
Preclinical and nonclinical drug development is a critical component of drug development and making poor or misinformed decisions can significantly delay or kill a drug, and waste valuable resources and investments.
The goal of preclinical and nonclinical research must be strategically designed and aligned to support a drug approval. In addition, vital issues need to be considered early, such as the timing of “must have” and “nice to have” studies, as well as issues ranging from which animal species would be most appropriate, to which facility can validate the bioanalytical assay or scale up and supply GMP API.
CSSi LifeSciences™ provides strategic guidance, planning and execution to save you time and costs.
Transforming a new drug or biologic entity into a treatment opportunity is a complex, expensive, and time-sensitive process. We help you navigate through the clinical development process through all clinical phases.
PHASE 1 STUDIES
Simplifying the drug development pathway while planning for contingencies requires clinical expertise and experience. CSSi LifeSciences™ is a proven partner that ensures that First-in-Human Phase 1 studies are designed to reduce time and expenses.
PHASE 2a/2b STUDIES
Based on the goals and early signs of safety and activity from the Phase 1 study, CSSi LifeSciences™ supports Phase IIa outcomes on an accelerated basis for approval through our integrated and adaptive study approaches. More importantly, our design methodology and operationalizing of studies increases success while considering the financial constraints. Following a successful proof-of-concept study, the product can progress to a Phase 2b or a Phase 3 study.
PHASE 3/3B STUDIES
CSSi LifeSciences™ has proven capabilities in advancing new drugs through late-phase clinical trials through well designed, Phase 3 studies, while obtaining rigorous data to satisfy multiple stakeholders, regulatory agencies, physicians and payers. Whether you need to position a product through comparative studies, develop line extensions or extend label claims, our process is designed to expedite study completion.
PHASE 4 AND EXPANDED ACCESS STUDIES
For a new drug to reach its intended market after launch, companies will need to:
Conducting an Expanded or Managed Access Program (EAP/MAP), whether under a Treatment IND, Emergency Use Protocol, Compassionate Use or Named Patient Basis program, requires specialized strategies, skills and resources that are different than a conventional clinical study.
We have the expertise, experience, and infrastructure to help navigate the complex regulatory and logistical issues of expanded access programs worldwide. Our approach utilizes cost effective, centralized management of Expanded Access Programs, combined with integrated drug supply and logistics to support any size program or market segment.
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