PJI Biotech 

PJI Biotech

  Strategic Quality and Regulatory Management Consulting

Services

PJI Biotech can help you 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 an initial consult, a long-term consulting project, and retainer services. PJI Biotech provides strategic consulting services in the following areas: 


Enterprise Compliance Risk Management

Compliance Risk Assessment and Ranking

Due Diligence for Merger and Acquisition

Product/APR/PQR/CMC Gap Assessment

Data Integrity Assessment

PAI and GMP Inspection Readiness


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

Training and Education

Executive Leadership Support

Expert Advisor on Regulatory Issue Resolution

Executive coaching in Quality and Compliance