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Sajjadi Consulting brings technical expertise and broad based experience to organizations involved in the development of complex biologic products. We focus on helping clients identify product specific quality attributes and deliver high quality data packages internal and external decision makers to enable successful regulatory filings.
Controlling and communicating measurement uncertainty in results is critical to mitigating risks throughout the process. From early phase research through to establishing lot release specifications for safety, purity, strength, identity and potency, unexpected findings must be investigated. Assay design, development and validation studies are integral to understanding the critical quality attributes of a product and statistics guide the generation, analysis and review of scientific data to support regulatory filings.