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Tech Transfer & NPI Site-to-site and CDMO technology transfer, new product introduction, and the protocols that make a process portable. 2
Process Validation Validation master planning, process performance qualification, and continued process verification for commercial manufacturing. 4
Drug Product Formulation, fill-finish, lyophilization, and drug product development for biologics and advanced therapies. 4
CDMO Governance Contract manufacturer oversight, technical assessments, person-in-plant programs, and quality agreements. 2
Regulatory CMC IND, BLA, and NDA CMC authoring, PAI readiness, and inspection support for regulatory submissions. 1
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