Scouting, audit & validation of Marketing Authorisations
Are you a MAH of one or more dormant registrations that you want to dispose of? Contact us to transfer the MA to another interested MAH — after a thorough audit and validation of the complete file.
Transfer dormant MAs with confidence
Are you a Marketing Authorisation Holder (MAH) of one or more dormant registrations that you want to dispose of? Then contact us to transfer the MA to another interested MAH after an audit and validation of the complete file.
During the audit of the dossier, its completeness and the correct compliance with LCM — or Life Cycle Management — are checked: are the 5 modules of the dossier complete and up to date to allow further production and distribution? Are all legal requirements regarding RA, RIP, PV, QP and RP fully respected?
Discuss your dossierWhat we verify during the audit
- Completeness of all 5 dossier modules
- Correct Life Cycle Management (LCM) compliance
- Readiness for further production & distribution
- Legal requirements for RA, RIP, PV, QP and RP
From audit to validated transfer
Dossier audit
We check the completeness of the dossier and the correct compliance with Life Cycle Management. We verify that all 5 modules are complete and up to date to allow further production and distribution, and that all legal requirements regarding RA, RIP, PV, QP and RP are fully respected.
Deficiency list
After the audit, a list of deficiencies is documented and communicated — giving you a clear and transparent overview of the current state of the dossier.
Audit report & CAPA plan
An audit report is prepared to categorize all gaps as critical, major and minor. Recommendations are made to provide a CAPA plan for remediation. Timelines are communicated in a workable calendar along with a budget.
Validation & feasibility
During the final validation phase, the feasibility of the transfer is discussed with the future MAH — as the total cost of the process in terms of time and budget is weighed against undertaking a new registration from scratch.
How we categorize gaps
Every gap identified during the audit is categorized so you know exactly where to focus remediation efforts.
Critical
Gaps that must be remediated before any transfer or further production can take place.
Major
Significant gaps that require attention and a clear remediation plan within agreed timelines.
Minor
Smaller gaps that should be addressed to keep the dossier fully compliant and up to date.
There is a commitment of effort but not a commitment of results; however, the best possible outcome is always strived for.
MA Scouting & Audit
What is MA scouting and validation?
What happens during the audit of the dossier?
How are gaps in the dossier categorised?
Do you guarantee that the MA transfer will succeed?
How do I dispose of a dormant marketing authorisation?
Have a dormant MA you want to transfer?
Contact us to discuss an audit and validation of your dossier. We'll help you assess the feasibility of a transfer to an interested MAH.