Our Services
Regulatory Affairs Consultant
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 an initial consult, a long-term consulting project, and retainer services. PJI Biotech provides strategic consulting services in the following areas:
Compliance Risk Management
- Developing Remediation Strategies and Strategic Plans
- Baseline Six-System Gap Assessment
- Quality Management Maturity Assessment (QMM)
- Due Diligence for Merger & Acquisition
- PAI and GMP Inspection Readiness
- Data Integrity Assessment
- Health Authority (483) Response Support
Quality Strategic Planning and Quality Systems
- Developing Quality Management Strategies
- Phase-Based Quality Systems
- GLP/GMP/GCP Qualification Audits
- Quality Agreements
- Batch Disposition and Quality Oversight
- Product Quality gap Assessment
- Quality Unit Start-up
- On-going Quality Support
Quality Control, CMC and Regulatory
- Development of QC Strategies
- Phase-Based CMC Quality Strategy
- CMC Quality Gap Assessment
- On-going CMC Quality Support
- CMC Regulatory Submissions
- Lab Equipment Qualification
- OOS Investigation and Issue Resolution
- Stability/Analytical Programs/Data Assessment
- Comparability and Change Management (Pre and Post-approval)
Executive Leadership Support
- Expert Advice on Regulatory Issue Resolution
- Executive coaching in Quality and Compliance