Our team will work closely with you to assess your current pharmacovigilance needs and help you develop and implement a customized plan to ensure compliance with regulations and standards. We also provide training to your team to ensure they have the knowledge and skills to maintain compliance and prepare for inspections.

Pharmacovigilance Services

We can provide end-to-end Individual Case Safety Reports (ICSRs) processing, Aggregate reports (All formats), Signal Management, and Regulatory Intelligence.

Pharmacovigilance Systems

We can review your existing PV system or implement a robust new one so that your PV system to withstand regulatory inspection scrutiny.

Audits

We can conduct mock inspections to help you identify gaps in your PV processes and other improvement opportunities.

System Validation

Ensure computer system compliance with GxP requirements. We can conduct computer system validation to ensure compliance with Health Canada and ICH Annex 11 and the FDA 21 CFR Part 11 regulations.

Standardization

Establish consistency in PV processes and procedures. We can create standard work instructions (SOPS) and process documentation.