PHARMACOVIGILANCE AUDIT & COMPLIANCE

• Pharmacovigilance system audits (e.g. GVP)

• REMS / RMP compliance audits

• Reference Safety Information (RSI) maintenance and compliance

• Audit and Inspection readiness 

• PSMF management

​​

MARKETING AUTHORIZATION & LABELING COMPLIANCE

Analyze and evaluate compliance with current laws and regulations in the following areas:​

• Marketing Authorization Compliance

• Labeling, Product Information, Artwork and Commercial Packaging

• Regulatory Affairs compliance (including process review and SOP/guidance document preparation)

• Audit existing global and national labels, processes and systems; propose and implement improvements

​​

AUDIT & CAPA MANAGEMENT

​Audit current processes and systems

• Global and local risk assessment and risk mitigations

• Ensure consistent global and local processes

• Review current regulatory systems, propose improvements or new systems

• Remote audit process available, utilizing standardized web-based forms and procedures

​

Training Management

• Prepare relevant trainings, develop training plans and conduct global/local trainings including train the trainer

• Revise current training tracking systems propose new customized systems

​​

Implement corrective and preventative actions (CAPA)
Develop SOPs, working practices, working instructions and related templates

​
​