Execute with confidence across all stages of the CMC development process
From technology transfer and comparability studies to process validation and CMO selection, we help biopharma teams execute with confidence across every stage of CMC development.
We specialize in aligning your manufacturing strategy with global regulatory expectations to enable timely submissions and de-risked scale-up.
How we work
Whether you're preparing your first GMP batch or planning for commercial-scale validation, Harmony ensures your manufacturing systems meet FDA and EMA expectations-while avoiding costly delays or misaligned partnerships. Our approach prioritizes data integrity, regulatory alignment, and long-term scalability. We offer full-spectrum support including:
Technology transfer planning and execution for both drug substance and drug product
CMO selection and oversight, including evaluation of technical fit and regulatory track record
Process validation strategies that define and justify Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
Onshoring and supply chain strategy for global production alignment
Case Study
End-to-end process validation for biologics program
A commercial-stage biologics company turned to Harmony to lead process validation for both drug substance and drug product manufacturing in preparation for BLA submission. Harmony defined CQAs and CPPs, established process ranges, and developed a robust FDA-aligned validation protocol.
Three
successful full-scale
validation batches
Validation data package accepted in BLA submission
BLA approved with no additional CMC questions from FDA
Chief Operating Officer
Commercial-Stage Biologics Company
"Harmony brought structure, efficiency, and scientific rigor to our manufacturing scale-up and validation program. They implemented a well-governed process that ensured we captured all critical data to support our BLA submission. Their understanding of regulatory expectations and ability to drive cross-functional alignment made them a trusted extension of our internal team."
FAQ
Absolutely. Harmony brings extensive experience in identifying and aligning with best-fit CMOs and CROs across a wide range of modalities and global geographies. We specialize in strategic onshoring decisions and scaling partnerships that align with your product lifecycle and commercial objectives. In addition, we expertly negotiate Master Service Agreements (MSAs) and Quality Agreements to ensure robust protection of your intellectual property, data integrity, and decision-making authority throughout the engagement.
Process validation begins with defining and understanding the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) that shape your product's performance and safety profile. Harmony partners with your technical and regulatory teams to design validation strategies that are fully aligned with FDA expectations, including the development of scientifically sound protocols and definition of the design space.
Our team has successfully led validation efforts across multiple dosage forms-including parenterals, topicals, and solid oral dosage-and complex biologics, with full support for FDA licensure submissions. We bring deep technical insight, regulatory fluency, and operational excellence to every engagement.