We provide Consulting Associates with expertise in several technical areas: CAPA, Auditing, Management Review, Risk Analysis, Document Control, Sterilization, Process Validation, Software Validation, Performance Scorecard, Part 11, Stability, Process Mapping, Materials, Training, Human Resources, and Laboratories.
We also perform project management and develop Compliance Master Plans for companies facing FDA challenges. We have several consultants who are ex-FDA Investigators and Compliance Officers. We can perform mock-inspections at your facility and assist during FDA inspections. We can review FDA 483s and Warning Letters and other correspondence between you and FDA - making recommendations from ex-FDA and Industry perspectives.