Your guide through every phase of BARDA and government funding
Harmony Biotech Consulting helps life sciences companies secure non-dilutive government funding through BARDA, ASPR, DoD, NIH, DARPA, ARPA-H, and other U.S. and international agencies. From TechWatch meetings and white paper submissions, to proposal development, contract negotiations and program execution, our embedded experts will be your trusted guide.
How we work
Our services cover the full lifecycle of federal contracting and proposal strategy, including:
Opportunity identification and submission planning for BARDA, DoD, ASPR, ARPA-H, CEPI, NHS, and global agencies
TechWatch meeting preparation and white paper development tailored to agency-specific review criteria
Full proposal writing and cost proposal development that maximize funding potential
Contract negotiation, project management, DCAA/DFAS compliance, and closeout support
Whether you're responding to the BARDA BAA, preparing for a critical TechWatch presentation, or seeking funding for onshoring manufacturing under Reshore Rx, we bring deep regulatory and development expertise to each engagement. Harmony is known for rapidly understanding your technology, identifying program gaps, and building government-aligned development plans that secure funding and drive execution.
Case Study
Secure government funding without regulatory delays
During the COVID-19 emergency, a major U.S. vaccine manufacturer turned to Harmony to lead the rapid development of a BARDA proposal from scratch. Harmony created a complete technical and cost proposal covering clinical trials, manufacturing, regulatory, supply chain, and program management. The proposal was submitted under urgent timelines for BARDA/Operation Warp Speed.
$1.8 billion
in government funding awarded
Largest biotech grant to date under BARDA/Operation Warp Speed
Ongoing partnership for contract, CMC, and program management support
Successful vaccine produced and commercialized under EUA and BLA
Why combining technical strategy with BARDA funding drives better outcomes
Most firms treat funding, regulatory, clinical, and CMC planning as separate workstreams. That disconnect often leads to:
- Misaligned proposals
- Delays in contract execution
- Increased risk during review and development
Harmony Biotech Consulting integrates these strategies directly into BARDA and government funding efforts, ensuring your program is viable from both a funding and approval perspective.
What this means for you:
- Stronger, more credible proposals
- Faster contract negotiation and activation
- Reduced technical risk across development milestones
- Greater confidence with agency reviewers
Explore our regulatory and other consulting services to see how we help clients stay ahead of compliance requirements while advancing funded programs.
Insights & Expert Perspectives for Biotech Companies Seeking Quality Support
Staying ahead of evolving regulatory expectations requires more than compliance - it demands continuous learning, strategic foresight, and operational excellence. Harmony Biotech Consulting shares expert insights to help biopharma, pharmaceutical, and life sciences teams navigate the complex realities of GMP quality systems, validation strategies, and global regulatory compliance.
Our latest thought leadership explores critical topics shaping modern quality organizations.
Trends in BARDA Funding and What They Mean for Emerging Biotech Companies
The Biomedical Advanced Research and Development Authority (BARDA) plays a vital role in supporting innovative biotech companies that develop products to protect public health. BARDA funding has shaped the life sciences landscape by accelerating vaccines, therapeutics, diagnostics, and medical countermeasures. For emerging biotech firms, understanding current trends in BARDA funding is critical to securing grants…
Is Your Biotech Company Eligible for BARDA Funding? A Step-by-Step Assessment
Biotech companies aiming to develop medical countermeasures often wonder if they qualify for funding from the Biomedical Advanced Research and Development Authority (BARDA). This article will provide a detailed, step-by-step guide to help you assess your company’s eligibility for BARDA funding. Understanding this can open doors to critical financial support for advancing vaccines, drugs, diagnostics,…
Understanding BARDA Funding: Grants, Contracts, and Partnerships Explained
Public health emergencies and biothreats require fast, focused innovation. The Biomedical Advanced Research and Development Authority (BARDA) plays a critical role in this space. If you work in biotech, pharmaceuticals, or public health, knowing how BARDA funding works can open doors to funding that accelerates your development. This article provides a clear, detailed guide to…
Chief Commercial Officer
Vaccine Manufacturer
"Harmony Biotech Consulting guided us through the government funding process, helped us develop our program, wrote our proposal, and got us the largest biotech government grant during Operation Warp Speed. We've worked with them ever since-they made sure we got the most value from the contract possible"
BARDA funding and regulatory strategy FAQs
The process typically includes:
- Monitor government announcements for funding opportunities
- Match government needs to company technology
- Notify government of company interest
- Meet with government representatives
- Submit an initial white paper or abstract
- Incorporate feedback and submit a full proposal
- Contract negotiations
- Receive award and begin development
Requirements vary by program and technology. Generally, funding is non-dilutive and supports government unmet needs. The government often requires:
- A specific phase of development having been reached (non-clinical, early-clinical or late clinical)
- Show clear path forward to licensure
- Company must have freedom to operate with intellectual property
- Plan for eventual commercial success
- First-right-of-access in emergencies of products developed with government funding
Yes. With 30+ years of drug development experience, Harmony identifies gaps in your plan and creates solutions to meet government requirements.
Yes. We frequently manage both technical and cost proposals, but can also support cost proposals only. Our goal is to maximize the funding amount and its effective use. We can also help with guidance on indirect rates and government accounting standards.
Absolutely. We've led many TechWatch meetings and know how to tailor presentations to BARDA's priorities. Harmony also holds the record for the most-attended TechWatch meeting (108 attendees across BARDA, DoD, NIH, NIAID, JPEO, and others).
The U.S. government is prioritizing domestic pharmaceutical manufacturing, with programs like the Reshore Rx initiative. Harmony has secured over $100M in onshoring funding and continually tracks new opportunities. We can connect you with the right programs and partnerships to support your business.
BARDA funds projects that develop medical countermeasures like vaccines, therapeutics, diagnostics, and devices to defend against chemical, biological, radiological, nuclear threats, and pandemics.
The process can take several months, including proposal preparation, submission, review, and negotiation phases. Early planning is essential.
A clear plan to achieve FDA approval or Emergency Use Authorization is critical because BARDA funds advanced development aimed at licensed or emergency-ready products.
TechWatch meetings are early discussions with BARDA program officers to get feedback on your technology concept before submitting a full proposal. They help align your development plan with agency needs.
Yes, BARDA provides non-dilutive funding, meaning companies do not give up ownership in exchange for the grant or contract.
Combining regulatory and funding strategy ensures your proposal is not only compelling to reviewers but also feasible from a development and approval standpoint. This reduces the risk of delays, rework, or compliance issues after funding is awarded.
Agencies like BARDA evaluate both technical innovation and execution readiness. A well-defined regulatory pathway strengthens credibility, demonstrates feasibility, and increases confidence in your ability to deliver on program milestones.
Yes. When regulatory considerations are built into the proposal from the start, contract negotiations and program activation move faster because fewer gaps need to be addressed post-award.
Biotech, pharma, and medtech companies developing vaccines, therapeutics, diagnostics, or advanced manufacturing solutions benefit significantly, especially when pursuing large-scale government funding.