CSSi LifeSciences logo — Provides regulatory solutions to pharmaceutical and medical...

CSSi LifeSciences

Provides regulatory solutions to pharmaceutical and medical device companies.

United States United States 10 employees Medical Devices, Pharmaceutical

General Information

Company Name CSSi LifeSciences
Location United States United States +1
Employees 10
Industries Medical Devices, Pharmaceutical
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About CSSi LifeSciences

CSSi LifeSciences provides regulatory solutions to pharmaceutical and medical device companies. The company's goal is to ensure a successful and expeditious pathway to commercialization for clients' drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. CSSi LifeSciences has an impressive track record, having commercialized over 500 new drugs, biologics, medical devices, and in-vitro diagnostics, and successfully completed over 250 medical device 510(k) Class 1-3 submissions with 100% success. They have also excelled in areas such as Orphan, “First in Class,” and “First In” Indication success, reducing time to approval by over 600 days, and achieving over 100 NDA, ANDA and BLA submissions with 96% success. CSSi LifeSciences Medical Device CRO expertise extends to navigating regulations in over 100 countries. With a deep understanding of the complexity and ambiguity surrounding medical device commercialization, they focus on impacting the timeline of regulatory clearance and increasing profitability. Overall, CSSi LifeSciences stands out for its extensive experience, successful track record, and global reach in providing regulatory solutions for pharmaceutical and medical device companies.

Taxonomy: Regulatory Solutions, Pharmaceutical Commercialization, Medical Device Commercialization, Drug Commercialization, Regulatory Pathway, Medical Device CRO, Global Regulatory Filing, Clinical Study Planning, Quality Management Systems, Orphan Indication, Medical Device Submissions, EMA CHMP Marketing Authorizations, SmartStudy Design, Protocol Amendments, Preclinical and Clinical Studies

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FAQ About CSSi LifeSciences

Provides regulatory solutions to pharmaceutical and medical device companies.
CSSi LifeSciences is headquartered in United States.
CSSi LifeSciences operates in the following industries: Medical Devices, Pharmaceutical.
CSSi LifeSciences has approximately 10 employees.
Top alternatives and competitors to CSSi LifeSciences include Alterra Medical, iO life science, Clinvigilant Research, Pharmakos Consulting d.o.o., MedRes - Medical Research Engineering. These companies operate in related industries and serve comparable markets. You can compare them side by side on Bounce Watch.
CSSi LifeSciences and Alterra Medical are both companies in similar industries. Compare their funding, team size, growth signals, and market position on Bounce Watch to see which one fits your needs.

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