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Leírás
Precision Scientific Consulting, Inc. was established in 2004. We provide regulatory compliance and validation consulting services for clients in the pharmaceutical and biotechnology industries. We specialize in biological manufacturing processes used in the production of monoclonal antibodies and vaccines. We have completed numerous projects for the start-up of new manufacturing facilities, licensing of new drug products, technology transfer and scale-up, FDA Form 483 remediation, qualification of aseptic processing areas, regulatory gap analysis, project master plans and large and small equipment qualification projects.
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