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.

  1. 01WDA(H) application readiness

    Evidence, accountable ownership and unresolved risks remain visible.

  2. 02Product-specific PLPI assessment

    Evidence, accountable ownership and unresolved risks remain visible.

  3. 03QMS and SOP governance

    Evidence, accountable ownership and unresolved risks remain visible.

  4. 04GDP and vendor oversight

    Evidence, accountable ownership and unresolved risks remain visible.

  5. 05Pharmacovigilance and recall readiness

    Evidence, accountable ownership and unresolved risks remain visible.

  6. 06Batch and document integrity

    Evidence, accountable ownership and unresolved risks remain visible.

  7. 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.

Pharmaceutical packaging and controlled batch documentation
Representative traceability context; no active NovaPharm batch or inventory is depicted.