Efficient and audit-proof systems designed for your unique needs
Whether you're preparing for your first IND, scaling up for Phase 3, or responding to global regulatory demands, we build GMP-aligned systems that drive operational excellence and compliance. We understand that quality systems must be both efficient and audit-proof. That's why we approach each engagement with the goal of making quality a growth enabler rather than a bottleneck.
How we work
Whether you're onboarding new manufacturing equipment, preparing for QP release in the EU, or facing heightened regulatory scrutiny, we embed practical, audit-ready quality controls into your operations. Our systems are designed to evolve with your program to support both clinical execution and commercial scale-up. Our services span:
Development of Quality and Validation Master Plans appropriate to product phase and technology
Validation of equipment, processes, and computerized systems (IQ/OQ/PQ, CSV)
Design and implementation of Quality Management Systems (QMS), including SOPs, EDMS, and vendor oversight
Compliance infrastructure for deviations, CAPA, and global inspection readiness
Case Study
Global quality documentation modernization
A multinational biotech company engaged Harmony to modernize SOPs and quality documentation at a newly acquired manufacturing site. Harmony integrated global and site-specific regulatory standards into existing document control workflows and led the update of over 100 SOPs, validation reports, and batch records.
Streamlined
global compliance across
legacy and new systems
Operational efficiency improved across departments
Site fully prepared for global regulatory inspections
VP, Regulatory Affairs & Quality Assurance
Biologics Manufacturer
"As a complex, multi-site GMP manufacturing operation, we required a highly customized quality system. Harmony's expertise and collaborative approach helped us develop robust procedures that supported our Phase 3 pivotal trial and maintained compliance across all sites."
FAQ
Even at the early stages, your quality systems must meet the expectations outlined in Phase 1 GMPs and related regulatory guidance. You'll need well-documented procedures that ensure control over manufacturing, as well as robust testing for identity, purity, potency, and safety.
Harmony works with clients to design and implement right-sized quality systems that are phase-appropriate yet scalable-ensuring alignment with FDA expectations and positioning your program for smooth IND submission and clinical startup.
Any new equipment used in GMP manufacturing or testing must be qualified and validated to demonstrate consistent performance within predefined specifications. This typically includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Harmony develops tailored Validation Master Plans that address equipment, utilities, processes, and computerized systems. We also oversee validation execution to ensure compliance with FDA and global GMP standards-supporting inspection readiness and minimizing operational risk.
Obtaining Qualified Person (QP) release is a critical regulatory step for conducting clinical trials in the EU and UK-and it differs significantly from U.S. product release practices. The QP review process involves more than just reviewing final release test results; it includes a comprehensive assessment of the entire manufacturing process, batch records, deviations, change controls, and the overall state of the quality system.
QP expectations are guided by EU GMPs and EMA guidance, and maintaining a collaborative, transparent relationship with your QP is essential. Timely, complete, and well-documented responses to QP inquiries can directly impact your clinical timeline.
Harmony brings deep expertise in navigating QP release requirements. We ensure your manufacturing and quality documentation is fully aligned with EU/UK expectations and can liaise directly with QPs to support efficient and compliant product release-keeping your trials on track and regulatory risk to a minimum.