Description
A biologics site needed a regulator ready plan to address inspection findings and restart sterile operations. Global Coalition acted as introducer and curator to assemble a quality and validation team and deliver independent assurance.

Blocker
Observations on aseptic practice, data integrity and deviation management created risk to batch release and licence conditions.

Mandate
Produce an evidence based remediation plan, align with EU good manufacturing practice and prepare for EMA and national inspectorate audit within six months.

What we did

Curated a senior quality lead, digital validation experts and a former inspector for independent assurance.

Ran a triage of critical lines, built a risk ranked remediation plan and closed gaps in training and documentation.

Implemented electronic validation and controlled document workflows with audit trails.

Prepared regulator ready submissions and hosted mock inspections.

Outcome
Partial restart achieved in four months, full capacity by month six. Inspection closed with commitments tracked under programme governance.

Keywords
regulatory assurance, regulator ready plan, independent assurance, evidence based remediation, GxP compliance, data integrity, audit readiness, EMA inspection, quality triage, programme governance