Due Diligence · MA Transfer · WRPA
Regulatory due diligence and marketing authorisation transfer
When products are bought or sold, the state of their marketing authorisations decides value and timeline. I review the regulatory status and manage the transfer through to the last market.
Due diligence
- Status of every authorisation per market: valid, renewal due, sunset-clause risk
- Open variations, conditions and commitments
- Dossier checked against actual manufacturing
- Pharmacovigilance status and open PSUSAs
- Traffic-light assessment with an action list
MA transfer
- Transfer plan across all markets
- Applications and health authority correspondence
- Alignment with supply chain, QA and pharmacovigilance
- Packaging and artwork change-over
- Programme governance with RAID log and stage gates
Experience
16 years at MEDA Pharma, which became part of Mylan and then Viatris during that time – two group integrations seen from the inside, with everything they mean for authorisation portfolios, responsibilities and supply chains. This included coordinating marketing authorisation transfers across multiple markets. As a Regulatory Affairs Specialist I handled variations and renewals in EU procedures (MRP, DCP, CP, NP) and international markets; as Senior Project Manager I led more than 20 lifecycle and portfolio expansion projects across 100+ markets. That is the combination a due diligence needs: reading the regulatory status of a portfolio – and knowing what it takes to put it right.
Next step
Available at short notice for mandates across the EU.
Freelance and interim mandates available now – remote, hybrid or on site in the Frankfurt Rhine-Main region.
Tell me briefly about your project — or book a 30-minute call directly.