Regulatory & Quality
No regulated supply before the required permissions.
The NovaPharm pathway connects company authority, product responsibility, quality systems and release evidence in a sequence that can be reviewed.
Regulatory foundation
A roadmap built around accountable gates.
Each stage has its own evidence, owner and completion criteria. Progress in one stage does not silently satisfy another.
- 01WDA(H) application readiness
Evidence, accountable ownership and unresolved risks remain visible.
- 02Product-specific PLPI assessment
Evidence, accountable ownership and unresolved risks remain visible.
- 03QMS and SOP governance
Evidence, accountable ownership and unresolved risks remain visible.
- 04GDP and vendor oversight
Evidence, accountable ownership and unresolved risks remain visible.
- 05Pharmacovigilance and recall readiness
Evidence, accountable ownership and unresolved risks remain visible.
- 06Batch and document integrity
Evidence, accountable ownership and unresolved risks remain visible.
- 07Commercial release only after applicable authorisation
Release follows the applicable permission and completed operating controls.
Batch integrity
Evidence should travel with every governed product and transaction.
Product identity, source, status, documentation, conditions and decision history need a consistent chain of evidence.

