Quality authority is designed to be independent.
The quality system is intended to grow in step with the first portfolio so external partners, clinical programs, technology transfer, manufacturing, and launch activities operate to consistent standards.
Patient safety, data integrity, and product quality come first.
Quality is intended to have escalation rights and management visibility from the beginning, with document control, change control, deviations, CAPA, training, vendor qualification, validation, and inspection readiness built into the operating model.
Clinical / GCP
Vendor qualification, protocol and site oversight, data integrity, safety reporting, trial master documentation, and inspection readiness.
CMC / GMP
Supplier and site qualification, method and process control, validation strategy, batch disposition, stability, complaints, and quality agreements.
Pharmacovigilance
Safety governance, case-processing model, signal management, partner responsibilities, reporting timelines, and post-approval readiness.
Data / Privacy / Security
Controlled access, validated systems where required, data integrity, privacy, cybersecurity, and cross-border information governance.
Commercial Compliance
Medical and promotional review boundaries, HCP interactions, contracting controls, fraud-and-abuse review, and documentation.
Partner Quality
Quality agreements, clear accountability, partner controls, continuity planning, and issue escalation across the external network.