EPV Services

- 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

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

- 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