Pharmaceutical Consulting

Project Deliverables.

The top two deliverables at each level, ranked by criticality index. Each is scored on patient and product impact, regulatory exposure, and scope of change, then scaled so the most critical equals 100.

1. 01

   FDA response and remediation

   Structured remediation actions and a path forward after agency observations, then oversight of multiple remediation efforts through closure.

   Reproductive health pharma, NJ · Plasma-derived therapies, IL
   Critical100
2. 02

   Sterility assurance investigations

   Media fill evaluation after incubation, and sterility investigations covering EM and PM excursions, deviations, and trends.

   503B outsourcing facility, NJ
   Critical96
3. 03

   Regulatory submissions

   Prior approval supplements and CBE-0 and CBE-30 changes for carton and container closure, plus FDA drug application preparation.

   Reproductive health pharma, NJ · Plasma-derived therapies, IL
   Major86
4. 04

   Investigations and root cause

   Deviation investigations using the Is / Is Not method, with criticality assigned to quality attributes and process parameters.

   Plasma-derived therapies, IL
   Major80
5. 05

   Trend reporting to leadership

   Trend reports on environmental excursions, action limits, and nonconformances for senior leadership.

   Plasma-derived therapies, IL · Cell and gene therapy CDMO, TX
   Supporting60
6. 06

   SOP and master batch record revision

   SOP and MBR updates routed through global change control and the change review board.

   Plasma-derived therapies, IL · Generic drug manufacturer, NJ
   Supporting50