Ensuring unmatched support and expedited pathways to success.
The QNova Accelerator is differentiated by our investor and strategic centric focus from a proven team that knows how to lead, grow, and exit. Our goal is to help your company succeed by accelerating your product to a strategic exit or commercialization.
As a member of the QNova Accelerator, your company will have access to the leadership of QNova LifeSciences, integrating guidance on product development, regulatory affairs, and commercialization strategies. The QNova LifeSciences team has extensive US FDA regulatory experience spanning both therapeutics and medical devices as well as deep hands-on industry experience.
The QNova Team has made a difference through our expertise and resources to achieve unparalleled industry success.
- Over 85 FDA NDA, ANDA, CVM and BLA submissions.
- More than 200 successful medical device approvals.
- Over 150 indications in > 30 therapeutic areas.
- Experience with > 500 drugs and biologics.
- Extensive “First-in-Human,” Orphan, and “First in Class,” indication experience.
We serve as an extension of your management team for pre- and seed-based companies, offering guidance on de-risking your path to commercialization with the goal of delivering successful outcomes.
With access to strategic partnerships, investors, and expert mentors, QNova Accelerator provides the tools and networks to guide you towards fast-track success.
Our Value Proposition
What our program offers you:
- Expertise: Leverage industry-leading expertise on medical device and drug development regulatory affairs, capital raising and partnering.
- Regulatory Strategy: Develop tailored regulatory strategies identifying potential issues and/or barriers to FDA approval. We can help you formulate a regulatory strategy for the most expeditious, cost-effective pathway to commercialization or a value inflexion and enhance the likelihood of FDA approval.
- Strategic Partnerships: Build partnerships with CDMOs, CROs, and traditional and nontraditional strategic investors and government partners.
- Robust Ecosystem: Join a network of mentors and global stakeholders. We have a network of over 30 academic universities and over 10 government Economic Development Organizations. This means the life science networking and development reach will be strong and committed to your success.
- Commercialization Expertise: Leverage our track record to navigate the commercial landscape and market access by reviewing your marketing plan, investor deck, and investor pitch.
- Community: Join a powerful network of startup founders all committed to providing mutual benefit, and an open exchange of ideas and peer support.
The Accelerator Program Benefits and Deliverable
Hands-On Support
Preparing companies for their next step, whether product or market validation, raising capital, partnering, or business development.
- An initial 1-hour intake to review your technology, corporate goals and requirements.
- A dedicated Project Manager, with monthly check-ins and up to 12 hours of support during your participation in the accelerator.
Investor Readiness and Preparation
- Two 1-hour meetings to review your Business Strategy and value proposition and provide strategic development support.
- An intensive 2-hour Investor Presentation review with feedback on your pitch deck, presentation, 1-pager and/or white paper.
- Investor Pitch Practice to help sharpen your presentation skills with expert feedback through a 1-hour practice session.
- Access to our investor and strategic databases to help identify and align with potential investors.
- Guidance on access to non-dilutive US grants.
- Guidance on how to prepare for a stage appropriate capital raise.
- Introductions to our network of investors and strategics.
Global Regulatory Affairs Powered by QNova LifeSciences
- Dedicated 2-hour domain specific regulatory assessment to review your FDA regulatory strategy to ensure you are harmonized with the latest FDA requirements.
- Review strategies to accelerate your FDA approval and reduce costs.
- Assess your eligibility for FDA Special Designations to increase your valuation.
- Identify potential risks and gaps in your preclinical, safety, design, CMC and clinical programs.
Access To a Broad and Diverse Network
- Provide connections to potential strategic partners and experienced advisors.
- Provide access to talent acquisition and fractional team members.
- Promotion to a network of investors.
- Access to industry leading CDMOs, design firms, and CROs to support product development.
- Access to corporate life science service partners to support your commercial development program.
Specialized Educational Webinars
Bimonthly webinars will be tailored for early-stage life science companies led by industry experts on topics such as:
- Recent updates and guidances from the FDA.
- Investable commercialization planning that harmonizes to the US FDA.
- Crafting targeted strategies for successful life science product commercialization, focusing on value creation through a sustainable business model.
- Establishing a competitive edge in and preparing a compelling pitch deck for investors and strategics.
- Best practices for engaging with early seed investors.
- Non-dilutive government funding updates from the NIH and DoD.
- Working effectively with government trade partners.
- Understand the key business principles and processes for life science companies.
- Best practices for structuring an IP “Fortress”.
- Defining a clear development timeline and articulating time-based KPIs to drive velocity to market.
- Communication strategies for greater impact through an impactful publication plan.
- Managing a board of directors, including how to run effective board meetings.
- Gaining visibility and investor recognition and engaging partners to maximize accomplishments.
J.P. Morgan Healthcare Conference
Maximize your opportunities by connecting with strategic investors and industry partners seamlessly through the QNova LifeSciences Annual Partner Forum during J.P. Morgan Healthcare week, January 12-15, 2026.
This exclusive, free networking event provides a unique opportunity for companies to:
- Connect with strategic investors, including family offices, private equity firms, angel groups, and venture capital firms.
- Engage with academic and economic development organizations to explore financial incentives and establish connections with high-level government officials.
- Learn about non-dilutive funding opportunities through grant programs like SBIR, BARDA, and others at the NIH, DoD, and NCI. Government representatives will be on-site to provide insights.
- Attend plenary sessions featuring industry leaders discussing the current and future state of biotech development and investment.
- Network with our strategic partners.
- Access to discounted hotel rooms at the Larkspur Courtyard Marriott Hotel.
Meet our Strategic Partners
Strategic Corporate and Government Advisory Partners
Legal and Financial Planning
Product Development
Incubators
Guidance from Industry Experts
Ensuring unmatched support and expedited pathways to success.
Who should apply?
Founders, startups from federal labs, university startups, and physician-entrepreneurs who are in the following life science sectors:
- Biopharmaceutical
- Pharmaceutical
- Medical Device
- Diagnostics
- Digital Health
- Veterinary Translational Medicine
- Health Technology
Membership Fee
No Equity Requirement
QNova Accelerator does not take equity in companies, as we are a fee-based organization and not a registered broker dealer.
No Application Fee
There is no fee for submitting your application to join the QNova Accelerator.
If your company is accepted for the 12-month program, the participation fee is $6,000.
Application
Use the following link to access the application.
About QNova LifeSciences
QNova LifeSciences is a global regulatory consulting CRO company that is powered by LifeSciences Regulatory Solutions, LLC.
QNova LifeSciences encapsulates our company’s mission to:
- Q stands for Quality, the cornerstone of our services.
- Nova, meaning “a star that shines brightly,” symbolizes guidance, innovation, and new beginnings. Just as a nova illuminates the night sky, we aim to shine a light on the regulatory process, guiding our clients through every stage of their journey.
Our name reflects the quality and innovation we bring to every partnership while staying true to our roots of guiding companies through complex regulatory and commercialization pathways to help life science innovators succeed.
The company is headquartered in Columbia, MD with an office in San Francisco, CA. Our office in Columbia is easily accessible to the FDA, NIH and the DoD. We specialize in providing strategic regulatory guidance for drugs, biologics and medical device technologies from discovery through commercialization in a manner that mitigates risk, time, and cost. Founded in 2014, QNova LifeSciences, whose corporate legal name is LifeSciences Regulatory Solutions, LLC, is registered with SAM.gov.
The goal at QNova LifeSciences is to ensure a successful and expeditious pathway to commercialization by providing insight driven analysis that enables faster and more informed decision making to increase commercial success. Our deep subject matter experts are comprised of experienced regulatory, scientific, and clinical drug and device developers in their respective fields. Early phase strategic planning and development of drugs are critical. Making poor or misinformed decisions can significantly delay or terminate a product and waste valuable resources and investments. We provide strategic guidance, planning and execution to save our client’s time and costs.
To apply, click the button below or begin filling out the form below:
Frequently Asked Questions (FAQs)
Q: What is the QNova Accelerator?
The QNova Accelerator is a 12-month, fee-based program designed to support early-stage life sciences companies by providing regulatory, commercialization, and investor-readiness support. Our team helps startups navigate product development, accelerate timelines, and prepare for strategic exits or commercialization.
Q: Who should apply?
A: We welcome applications from founders, startups, and teams in the following sectors:
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Biopharmaceuticals
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Pharmaceuticals
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Medical Devices
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Diagnostics
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Digital Health
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Veterinary Translational Medicine
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Health Technology
This includes university spinouts, federal lab technologies, and physician-led ventures.
Q: What makes QNova Accelerator different from other accelerators?
A: QNova Accelerator is led by a team with unmatched experience in FDA regulatory affairs and industry commercialization. We don’t take equity. Instead, we offer practical, investor- and strategy-focused support, drawing from a track record of over 85 drug and biologic approvals and 200+ medical device clearances.
Q: What’s included in the program?
A: Your company will receive:
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A 1-hour intake strategy session
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A dedicated Project Manager
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Up to 12 hours of monthly support
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Guidance on regulatory strategy, investor readiness, and business development
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Access to strategic partners, webinars, and investor events
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Invitations to high-impact networking events like our J.P. Morgan Partnering Forum
Q: What’s the cost to participate?
A: Application Fee: None
Program Fee: $6,000 for 12 months
Equity Requirement: None — we are fee-based and do not take equity or function as a broker-dealer.
Q: What kind of support will I receive from the QNova LifeSciences team?
A: You’ll work with our senior regulatory and commercialization experts. We assist with:
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Regulatory pathway planning
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Investor deck and pitch refinement
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Strategic connections to CDMOs, CROs, and funding partners
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Market access and commercialization planning
Q: When should I apply?
A: Applications are accepted on a rolling basis. We recommend applying early to secure a spot and begin receiving support aligned with your fundraising or development milestones.
Q: Will participating help me raise funding?
A: Yes. Our team helps you become investor-ready, connect with our investor network, and position your company for non-dilutive and dilutive funding opportunities. We provide access to private equity, family offices, VCs, and government funders.
Q: Can I join if I already have investors or existing partnerships?
A: Absolutely. We work alongside your current partners and investors to strengthen your development plan and extend your commercialization and regulatory capabilities.
Q: Do I have to be based in the U.S. to join?
A: No. While our headquarters are in Maryland and California, we accept international applicants. Many of our services are virtual, and we support global companies looking to navigate U.S. FDA regulatory pathways.
Q: What happens after the 12-month program ends?
A: Graduates may continue working with QNova LifeSciences through customized consulting, long-term regulatory support, or commercialization services tailored to their next phase of growth.
Follow for Updates
We’d love to keep you updated on our journey and share insights into our services.
- Follow us on LinkedIn for regular updates.
- Subscribe to our newsletter to stay informed about our events and industry news.
- Contact us to learn more about our rebrand or explore how we can support your projects.
Contact Us
Feel free to contact us with any questions.
Jim Sergi | President & Founder
info@QNovaLS.com
6751 Columbia Gateway Drive, Suite 300, Columbia, MD 21046
www.linkedin.com/in/jim-sergi/
QNova LifeSciences is a global regulatory consulting firm specializing in regulatory and commercialization services for drugs and medical devices. Known for its extensive FDA experience, we guide clients through complex regulatory landscapes with a commitment to reducing time and costs-to-market and enhancing commercial success.
If you are interested in partnering with us, please contact info@QNovaLS.com and a member of our team will get right back to you.