CSSi LifeSciences

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Contact Information

Jim Sergi
President and Partner
CSSi LifeSciences
6958 Aviation Blvd Suite H
Glen Burnie, MD 21061
USA
(415) 317-4903
(888) 509-6825 (fax)
jsergi@cssienroll.com
www.cssilifesciences.com
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Number of Certified CRAs: 95

Company Overview

The CSSi LifeSciences™ 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.

What We Do

The CSSi LifeSciences™ mission is to deliver quality outcomes and improved efficiencies across the entire product lifecycle with the goal of improving quality health outcomes for patients. Our core values form the basis for insight-driven strategic decision-making that ensure the best possible medical therapeutics and devices reach patients without delay, while creating shareholder value.

Our Global Expertise

CSSi LifeSciences™ is a global company headquartered in Baltimore, MD with offices located in San Francisco, CA, London, UK, and Hyderabad, India. We provide global perspective, with local execution. Our clients span the globe and include big- and virtual- biopharmaceutical companies, medical device and diagnostic companies, universities, incubators, and venture capital and private equity companies seeking to maximize shareholder value.

Our Partnerships Are Built On Trust

Leveraging scientific insight and strategic partnerships, the CSSi LifeSciences™ collaborative and client-centric approach has delivered consistent results. Our deep subject matter experts are of the most experienced regulatory, scientific, preclinical, medical, and medical device engineers in their respective fields.

What Makes Us Different

  • Experienced, flexible, and proven team
  • Accountability and transparency
  • Strategically focused and message driven
  • Deep and broad subject matter expertise
  • Streamlined from compound selection to commercialization
  • Comprehensive and scalable resources
  • Validated processes and innovative technologies
  • Median team member experience: >20 years

We Are a Fully Integrated Medical Device CRO

CSSi LifeSciences™ supports small and large companies in avoiding the “large CRO shuffle” by providing highly specialized regulatory and clinical expertise in medical devices, while also offering unparalleled and cost efficient services from start to finish. Our goal is to accelerate product development by providing insight-driven guidance that saves time and cost.

The CSSi LifeSciences™ medical device team has over 100 years of development and commercialization experience collectively, coupled with global regulatory knowledge, which goes beyond published guidance documents and initiatives. Our medical device experts serve as a liaison for device manufacturers from inception to commercialization, leveraging deep subject matter expertise and regulatory experiences to effectively move new products to market with speed, accuracy, and the quality necessary to ensure safety, compliance, and health authority approval. The CSSi LifeSciences™ team possesses the necessary skills and resources to make our clients’ medical device efforts an end-user success.

CSSi LifeSciences™ supports all phases of medical device development, from design engineering and testing to clinical studies and reimbursement. We offer a broad suite of scalable and fully integrated services, including:

  • Regulatory filings to US and foreign Notified Bodies
  • Clinical study planning, monitoring, and reporting
  • FDA and EMA Agent for Foreign Registration
  • Medical device testing and Design History Files
  • Quality Management Systems (21 CFR 820 and ISO 13485)
  • Health authority interactions
  • Regulatory and scientific communication

Contact Information

Jim Sergi
President and Partner
CSSi LifeSciences
6958 Aviation Blvd Suite H
Glen Burnie, MD 21061
USA
(415) 317-4903
(888) 509-6825 (fax)
jsergi@cssienroll.com
www.cssilifesciences.com
View Map

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