Effective strategies to meet operational and regulatory needs
From onshoring manufacturing and identifying CDMOs to navigating urgent quality crises, we deliver tailored strategies backed by deep regulatory and government engagement experience.
With a proven record of supporting over $1 billion in U.S. manufacturing infrastructure, we help you stay ahead of policy shifts, mitigate compliance risks, and build a more resilient supply chain.
How we work
We know clients often face urgent regulatory or infrastructure challenges. That's why our approach balances long-term strategy with rapid-response support. Whether securing qualified U.S.-based partners or restructuring your supply chain to meet domestic mandates, we bring clarity to complex projects and help you act with confidence.
Harmony integrates seamlessly with your internal team to deliver structure, speed, and regulatory rigor. Our work typically includes:
Strategic planning for onshoring, manufacturing expansion, or outsourcing
Site and CDMO selection grounded in GMP readiness, cost efficiency, and scale-up capability
Emergency quality remediation for GMP compliance and Warning Letter resolution
Government engagement to unlock funding opportunities and anticipate policy shifts
Case Study
Strategic quality remediation for ophthalmic device manufacturer
A commercial-stage ophthalmic device company faced escalating compliance risk: multiple FDA Warning Letters and the threat of a consent decree.
Harmony was brought in to stabilize and modernize the company's quality infrastructure. We developed and implemented a comprehensive Quality Master Plan and Validation Master Plan, introduced a modern electronic document management system (EDMS), and retrained staff to current cGMP standards.
75%
reduction in product failure rates
Closure of all FDA observations
Regulatory risk averted and product quality restored
FDA Regulatory Project Manager
"Thank you. You have been extraordinarily helpful in facilitating our communication with the company."
FAQ
With evolving federal policies aimed at strengthening domestic supply chains, early preparation is essential. Harmony brings over 15 years of experience working directly with the U.S. Government and has supported the onshoring of more than $1 billion in pharmaceutical manufacturing infrastructure-including API, drug product, and precursor production, as well as analytical testing capabilities.
We offer strategic guidance to help you navigate current and anticipated regulatory requirements, identify qualified U.S. or allied manufacturing partners, evaluate alternate raw materials or components, and restructure your supply chain to mitigate risks from tariffs, trade restrictions, and policy shifts.
Harmony has successfully negotiated on behalf of clients with key agencies such as HHS, DoD, DOE, FDA, BARDA, ASPR, and IBx, positioning us to help your organization align with national priorities while maintaining business continuity and regulatory compliance.
Selecting the right manufacturing partner is critical to ensuring product quality, regulatory compliance, and long-term supply chain resilience. Harmony has a proven, structured approach to site selection that we've successfully applied across numerous biopharma programs.
We evaluate GMP-qualified facilities based on technical capabilities, regulatory track record, cost efficiency, scalability, and geographic considerations. Our process includes detailed risk assessments, site audits, and support through contract negotiation and tech transfer planning-ensuring alignment with your product's clinical or commercial needs.
Harmony specializes in rapid-response quality and compliance support for high-stakes remediation projects. Our experienced teams can be deployed quickly to assess the situation, define a targeted and efficient action plan, and execute with precision-ensuring alignment with both your internal quality systems and regulatory expectations.
We focus not only on resolving the immediate issue but also on identifying and addressing root causes. Our approach includes practical, forward-looking recommendations to strengthen your quality systems and reduce the risk of recurrence.
Whether for clinical or commercial operations, across biologics, small molecules, or advanced therapies, Harmony has successfully led remediation efforts for both large global pharma and emerging biotech companies.