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Strategic Quality and Regulatory Management Consulting

PJI Biotech can help you to advance your compliance maturity level through collaborative efforts by assessing, prioritizing, planning, resolving and mitigating quality and regulatory compliance risks and opportunities. PJI Biotech offers an array of consulting services such as a trusted advisor, strategic partner, and retainer. 

PJI Biotech services portfolio includes consulting services in the following areas: 

Enterprise Compliance Risk Management

Quality and Compliance Risk Assessment and Ranking

Due Diligence support for Merger and Acquisition

Product Quality and CMC gap Assessment

PAI and GMP Inspection Readiness

Data Integrity Assessment

Global Strategic Planning

Risk-based Enterprise Strategic Planning

Quality Remediation Plan Oversight

Phase Based Compliance Strategy Development

Phase Based CMC Strategy Development

QC Facility and Quality Unit Start-up Planning

Quality Management

Quality System and Global Standards

QC Program Development

CMC Processes Development

Health Authority Inspection Response

Education and Training

Executive L​eadership Support

Expert Advise​ on Regulatory Issue Resolution

Executive coaching in Quality and Compliance