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This could involve tweaking experimental conditions, changing reagents or redesigning the assay. Regulatory and Compliance Knowledge Having knowledge of the regulatory landscape is particularly relevant in clinical diagnostics or pharmaceutical industries where the assays must meet specific regulatory standards.
Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline. But review issues are not the only problems.
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