Case Study: Top Biopharmaceutical Company achieves regulatory readiness and an actionable PASS roadmap with Advarra

Developing an Organizational Roadmap for Post Authorization Safety Studies

Top Biopharmaceutical Company, a large global R&D organization, faced entrenched legacy processes and documentation that threatened compliance and effective management of Post‑Authorization Safety Studies (PASS). To achieve Health Authority Inspection Readiness and demonstrate consistent governance across pharmacovigilance and quality functions, the company engaged Advarra — specifically Advarra Consulting Services — to perform a risk‑based assessment and develop an organizational roadmap for PASS implementation and oversight.

Advarra executed a five‑phase assessment, reviewing 196 documents and conducting 23 stakeholder interviews across 11 departments within three weeks, then delivered a detailed, actionable roadmap and implementation plan (including a single PASS model, QMS alignment, EU QPPV oversight, change management and training). As a result of Advarra’s work, the Top Biopharmaceutical Company consolidated PASS processes into a fit‑for‑purpose operating model, improved pharmacovigilance and safety data integrity, reduced FDA/EU regulatory risk, and identified immediate remediation opportunities within about five weeks — outcomes that led to clearer governance, improved compliance, and increased successful studies using Advarra’s framework.