Harmony Consulting Blog
Onshoring is not about abandoning global integration, it’s about recalibrating it. For biotech companies, the goal is a resilient, adaptive manufacturing network that balances efficiency with control. Domestic production can…
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Quality management in biotechnology has always been about walking a tightrope. On one side lies the imperative to protect patient safety through rigorous controls and documentation. On the other, the…
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For decades, biotech manufacturing thrived on globalization. A molecule might be discovered in Boston, scaled in Singapore, and filled and finished in Ireland — all part of an intricate web…
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Scaling a promising therapeutic from lab bench to commercial production is one of the most defining transitions in a biotech’s lifecycle. It’s also one of the most closely scrutinized. As…
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When the federal government shuts down, Washington D.C. doesn’t actually close — it constricts. For biotech organizations that rely on federal grants, contracts, regulatory interactions or collaborations with government-labs, a…
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Phase-Appropriate Development: #2 We need to comply with FDA requirements. How much is enough? If the basics are not in place, then development will not move forward. Studies will need…
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Phase-Appropriate Development: Part#1 FDA-regulated companies are always being told to do more. There are multiple new guidance documents per year, revisions of old rules, new technologies, new tests, new contaminants.…
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