Our Clients
Trusted by innovators at
Introduction to Harmony Biotech Consulting
Tailored biotech consulting solutions that keep your science moving forward, faster.
When regulatory delays threaten to derail progress, patients pay the price. At Harmony Biotech Consulting, we believe transformative therapies and technologies deserve to reach the people who need them - fast.
That's why our consultants work shoulder to shoulder with your team to break through complexity and keep development moving. With hundreds of successful engagements since our founding in 2011, we bring speed, clarity, and precision to every phase of your drug, device, diagnostic, or biotech program.
Our Promise
We stay ahead of evolving regulations so you don't have to. Whether you're navigating FDA scrutiny or building from the ground up, Harmony brings tailored expertise and a problem-solving mindset to help you move forward with confidence.
2011
Year
founded
>500
Projects
completed
15+
Years
in service
92%
Of clients
retained
How we work
Our nimble, expert consulting support is there for you every step of the way.
In high-stakes development, momentum matters. Harmony Biotech delivers expert guidance that moves as fast - and as precisely - as your goals demand. We integrate seamlessly with your team, eliminating delays and aligning our work with yours from day one.
Whether you're facing a single urgent milestone or need long-term, scalable assistance, we tailor our approach to fit your internal structure, timelines, and priorities. Our consultants are doers as much as strategists - solving problems, closing gaps, and keeping your program on track.
Chief Regulatory Officer
Emerging Biotech Firm
"Harmony's regulatory experts integrated with our team immediately, helping us go through a complex submission process while cutting our timeline by nearly 50%. Their ability to adapt to our changing needs while maintaining quality and compliance was invaluable."
CEO and Founder
Cell Therapy Company
"We were heading in lots of different directions at once. Harmony Consulting helped us narrow our scope and focus on our goals more quickly. They have such a broad base of experience that we know we can call them to answer any question or complete any project."
Introduction to Harmony's capabilities
From R&D to commercialization, we accelerate every stage of development.
Harmony Biotech is there for you through every stage of the development spectrum. Our consultants bring specialized knowledge to pharmaceutical, biotechnology, and medical device companies at every stage of growth - helping you navigate regulatory requirements, optimize operations, and expedite your path to market.
Quality and validation services consulting
Create systems that are audit-ready and built to scale. We help you implement quality frameworks that not only meet compliance needs but also improve day-to-day efficiency across your operations.
Regulatory services consulting
Turn regulatory complexity into a clear roadmap to approval. Our consultants guide in everything from pre-IND planning to global submissions - helping you avoid delays, respond to agency feedback, and strengthen your overall strategy.
Analytical services consulting
Deliver accurate, reliable results that meet both scientific and regulatory expectations. We develop and validate analytical methods that stand up to inspection - supporting everything from lot release to stability testing.
CMC and manufacturing services consulting
Streamline tech transfer and manufacturing with guidance from professionals who've done it before. Our team advises from scale-up to commercial production to ensure your product remains high-quality, consistent, and fully compliant at every stage.
Drug development consulting
Fast-track progress from preclinical to clinical trials with strategic planning and hands-on project leadership. We support all phases of development with practical guidance that keeps your timelines on track and your programs aligned with evolving scientific standards.
Operations consulting
Build a nimble, efficient organization with flexible staffing and targeted operational solutions. Whether you're scaling a biotech startup or optimizing mature systems, we help you solve real-world resourcing challenges without losing momentum.
Nonclinical services consulting
Move through the critical path from discovery to IND with confidence. From study design through execution, our team helps ensure your nonclinical data package is compliant, complete, and positioned to enable regulatory success.
Project highlight
Fueling biopharma innovation through strategic partnership.
A biopharmaceutical company needed to transfer manufacturing of their specialized radiolabeled antibody to a new facility and chose Harmony for their expertise. Harmony quickly sourced vendors, completed the transfer, and submitted to FDA within 6 months - all while maintaining quality and regulatory compliance.
$3M saved
per year in
manufacturing costs