CMC IND/BLA Roadmap, Strategy
& Operational Readiness Assessment

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Partner with client to develop Investigational New Drug (IND) / Biologics License Applications(BLA) / Computer-mediated communication(CMC) Roadmap (Module 2 and Module 3).
Assess operational readiness of: Investigational New Drug (IND) / Biologics License Applications(BLA).
Perform capability assessment to enable: Investigational New Drug (IND) / Biologics License Applications(BLA) / Personal Activity Intelligence(PAI).
Technical writing and authoring of: Investigational New Drug (IND) / Biologics License Applications(BLA).

(Environmental Monitoring Performance Qualification)

Assessment of facility processing environment to determine those areas that have the highest risks.

Partner with client to develop Investigational New Drug (IND) / Biologics License Applications(BLA) / Computer-mediated communication(CMC) Roadmap (Module 2 and Module 3).
Assess operational readiness of: Investigational New Drug (IND) / Biologics License Applications(BLA).
Perform capability assessment to enable: Investigational New Drug (IND) / Biologics License Applications(BLA) / Personal Activity Intelligence(PAI).
Technical writing and authoring of IND/BLA components.

CMC IND/BLA Roadmap, Strategy& Operational Readiness Assessment