Quality & Regulatory Leadership

Provide QA/RA leadership that stabilizes operations, closes critical compliance gaps, and prepares drug and biologic manufacturers for inspections and approvals. We embed experienced QA/RA leaders into your team to run GMP governance, lead sterile and aseptic-control programs, and own validation and release activities until permanent leadership is in place.

 

Key offerings

• Interim QA/RA leadership (on-site or remote)

• GMP program governance for sterile and non-sterile operations

• Process, cleaning and computerized system validation (CSV) oversight

• Batch-release governance, lot disposition and deviation management

• Deviation, CAPA and Change control lifecycle management and inspection preparedness
   

Typical deliverables

• Interim QA/RA onboarding brief & 30/60/90-day stabilization plan

• QMS remediation plan and prioritized CAPA closure schedule

• Validation status summary (process, cleaning, CSV) and batch-release SOPs

• Mock-inspection report and inspector Q&A brief
   

Client impact / outcomes

• Rapid reduction in high-risk compliance gaps and audit exposure

• Clear governance for batch release and deviations, reducing release latency

• Improved inspector readiness and higher confidence during regulatory interactions