EPV Services

Process & Improvement

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- Safety & PV SOPs, Policy, & WI Generation & Review

- PSMF Support, Templates, 

- PV System Gap Analysis 

- Organizational Structure Support (JDs, functional development)

- SAERF & Pregnancy Report Form Templates

- PV Agreements / SDEAs

- Protocol & IB Review

Training

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Assistance with the review and development of: 

- General and/or product specific Safety/AE training

- PV curriculum review & development for Safety & PV Professionals 


 

Topic Specific & Tailored Training - In person or Remote

- PSMF Management

- Developing a compliant PV Quality Management System

- GVP Training

- ICSR & Safety Narrative writing

- QC Principles & Practices

- Generating and Tracking Safety Letters & Effective communication

Quality & Compliance

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 - Auditing support, audit report & CAPA Plan templates and management

- PV Inspection Readiness & Training, Front & Backroom support and management

- GVP Annual and Strategic Plans with Risk-based Assessment strategies

- Compliance Metrics & strategies

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