CSSi LifeSciences
- Company typePrivate
- Founded-
- HeadquartersLinthicum Heights, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
CSSi LifeSciences firmographics
Firmographics- Name
- CSSi LifeSciences
- Legal name
- QNova LifeSciences
- Website
- https://cssilifesciences.com
- Company type
- Private
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Ownership category
- akta.pro rank
CSSi LifeSciences industry classification
Industry- Product category
- Regulatory Affairs Consulting (Drugs and Medical Devices)
- NAICS
- Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169), Management Consulting Services (54161)
- SIC
- Services-Management Consulting Services (8742), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- CMC Regulatory Affairs (Modules 2/3, Variations, Post-Approval CMC) (HLAGAKAB)
- akta.pro secondary industries
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG), Medical Writing & Clinical Documentation FSP (HLAGAOAC)
Keywords
Where CSSi LifeSciences is headquartered
LocationHeadquarters
- HQ city
- Linthicum Heights
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
CSSi LifeSciences business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D
Revenue model
- Regulatory Consulting Services: The company generates revenue through providing regulatory consulting and management services for drug and medical device companies seeking FDA approval. Services include strategic pathway development, health authority meetings, submission services, quality management systems, and medical writing.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
CSSi LifeSciences product offering
Product offeringCore offering
CSSi LifeSciences (now operating as QNova LifeSciences) is a global CRO and consulting group that provides customized regulatory, clinical, and commercialization solutions to advance therapeutics and medical devices through FDA approval and U.S. market entry. The firm delivers end-to-end services including regulatory strategy, submission preparation, medical writing, quality management systems, clinical trial management, project management, and U.S. market commercialization support.
Product overview
CSSi LifeSciences (now QNova LifeSciences) is a global CRO and consulting group specializing in advancing therapeutics and medical devices through development and regulatory approval. The company offers a unified platform of regulatory solutions including Drug Development Solutions, Medical Devices Solutions, Regulatory Services, Medical Writing, Quality Management Systems, and Commercialization Solutions (including U.S. Commercialization). The integrated service portfolio is complemented by Clinical Services and Strategy/Project Management capabilities to guide clients from discovery through commercialization, with particular focus on U.S. FDA approval processes.
Differentiator
Problem solved
Functional benefit
Products and services
- Drug Development Solutions Strategic pathway, consulting, planning and gap assessment, health authority meetings, and submission services for drug development through FDA approval. Designed for drug developers seeking IND, NDA, BLA, 505(b)1, and 505(b)2 submissions.
- Medical Devices Solutions Comprehensive regulatory consulting for medical devices including strategic pathway, planning, health authority meetings, and submission services through FDA CDRH. Targeted at medical device developers seeking Class I and II device approvals.
- Regulatory Services Expert guidance through the FDA approval process for novel drugs and medical devices, providing strategic regulatory consulting across drug and medical device programs.
- Medical Writing Professional medical writing services for regulatory submissions and documentation supporting FDA submissions for drugs and medical devices.
- Quality Management Systems Quality management system consulting and implementation supporting regulatory compliance for drug and medical device companies.
- U.S. Commercialization Comprehensive suite of customized services to help international life science companies enter the U.S. market and understand FDA regulations and business practices. Targeted at international companies seeking U.S. market entry.
- Clinical Services Clinical development services across all clinical phases to transform new drug or medical device entities into treatment opportunities, leveraging access to 700+ clinical sites.
- Strategy and Project Management Risk-based strategic roadmap providing an integrated and adaptive pathway to commercialization that mitigates time and cost across development, regulatory, clinical, and commercial phases.
Quantifiable outcome
- 100% Class 1 and 2 medical device approvals by U.S. FDA
- +4 more outcomes
Companies that use CSSi LifeSciences
Customer profileSegments2 records
Ideal customer profiles2 records
CSSi LifeSciences technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
CSSi LifeSciences partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Academic Incubators and AcceleratorscoreCSSi LifeSciences has partnered with over 15 academic incubators and accelerators. These partnerships support life science entrepreneurship by providing ecosystem services for early technology development and advancing strategic objectives for companies entering the U.S. market.
Scale indicators6 records
Recent moves6 records
Expansion highlights5 records
CSSi LifeSciences competitors and assessment
Company assessmentDirect peers
- ProPharma Group: ProPharma Group is a regulatory, compliance, and pharmacovigilance consulting firm serving pharma and medical device developers, directly overlapping with QNova's regulatory consulting, quality management systems, and medical writing offerings.
- NAMSA: NAMSA is a medical device-focused CRO offering regulatory, clinical, and quality consulting services. Like QNova, it serves device manufacturers navigating FDA CDRH approval pathways and combines consulting with operational trial support.
- Medpace: Medpace is a mid-sized global CRO providing clinical development and regulatory services across all phases, comparable to QNova's clinical and regulatory portfolio for drugs and devices.
- Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized CRO offering clinical and post-approval services across therapeutic areas, operating with a similar boutique-style, sponsor-focused model as QNova.
- CTI Clinical Trial & Consulting Services: CTI is a CRO providing clinical trial management, regulatory consulting, and therapeutic expertise, with comparable scale and a multi-therapeutic focus similar to QNova's service range.
- Celerion: Celerion is a CRO specializing in early-phase clinical research and bioanalytical services, comparable to the clinical development portion of QNova's offering for drug developers.
Emerging players
- Veristat: Veristat is a smaller, regulatory-focused CRO offering biostatistics, clinical, and submission services for drugs and biologics, with narrower scope than QNova but overlapping regulatory submission expertise.
Broad incumbents
- IQVIA: IQVIA is the largest global CRO offering end-to-end clinical, regulatory, and commercial services across drugs and devices. It competes broadly with QNova but operates at vastly greater scale and across all geographies.
- ICON plc: ICON plc is a leading global CRO providing clinical, regulatory, and consulting services to pharma and device sponsors, with overlapping capabilities but broader portfolio and global reach than QNova.
- Charles River Laboratories: Charles River Laboratories is a large CRO offering discovery, preclinical, clinical, and regulatory services, with overlapping capabilities to QNova but a much broader portfolio and global footprint.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
CSSi LifeSciences social profiles
Digital presenceCSSi LifeSciences financial estimates
Financial estimateRevenue estimate
Valuation estimate
CSSi LifeSciences leadership team
Management profileNumber of profiles
Profiles1 record
CSSi LifeSciences funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
CSSi LifeSciences M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about CSSi LifeSciences
What does CSSi LifeSciences do?
CSSi LifeSciences (now operating as QNova LifeSciences) is a global CRO and consulting group that provides customized regulatory, clinical, and commercialization solutions to advance therapeutics and medical devices through FDA approval and U.S. market entry. The firm delivers end-to-end services including regulatory strategy, submission preparation, medical writing, quality management systems, clinical trial management, project management, and U.S. market commercialization support.
Is CSSi LifeSciences a public or private company?
CSSi LifeSciences is a private company. It is classified as unknown and is currently operating.
When was CSSi LifeSciences founded?
CSSi LifeSciences was founded in -1. It employs 11 to 50 people.
Where is CSSi LifeSciences based?
CSSi LifeSciences is headquartered in Linthicum Heights, United States, in the North America region.
How does CSSi LifeSciences make money?
One revenue line is on record: regulatory Consulting Services.
Who are CSSi LifeSciences's main competitors?
Direct peers on record are ProPharma Group, NAMSA, Medpace, Worldwide Clinical Trials, CTI Clinical Trial & Consulting Services and Celerion. Veristat is listed as an emerging player. Broad incumbents are IQVIA, ICON plc and Charles River Laboratories.
Does CSSi LifeSciences have an API?
No public API is recorded for CSSi LifeSciences.
What industry is CSSi LifeSciences in?
CSSi LifeSciences's product category is Regulatory Affairs Consulting (Drugs and Medical Devices). Its primary akta.pro industry code is HLAGAKAB, CMC Regulatory Affairs (Modules 2/3, Variations, Post-Approval CMC), with a secondary code of HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight). Its NAICS code is 5417 and its SIC code is 8742.