Services — 01 / RA
EU variations and lifecycle management – interim support
Temporary coverage of an RA role or support for individual procedures: variations, renewals, PSUSA procedures and outcome implementation, health authority liaison and dossier maintenance — flexibly scaled from short-notice capacity bridging up to full role coverage. This includes national implementation of centralised procedures — product information, packaging and artwork.
- ✓Variations (Type IA, IB, II) — preparation, filing, health authority liaison and implementation of outcomes
- ✓Renewals and PSUSA procedures including follow-up and national implementation
- ✓National implementation of centralised procedures — product information, packaging and artwork
- ✓Dossier maintenance: Module 3 (3.2.S and 3.2.P) in the Global Core Dossier
- ✓Annual grouping under the new Variations Guidelines (mandatory since January 2026)
- ✓Global marketing authorisation management across EU, APAC, CIS, MEA and LATAM
From practice
Five projects — directly from this area
All projects are from my time at Viatris (formerly MEDA Pharma GmbH & Co. KG), Bad Homburg.
Manufacturer change with minimal regulatory overhead
Supported the transfer of manufacturing to a new contract manufacturer — implemented as a grouped variation instead of multiple separate procedures. Gap analysis before filing enabled the grouping; uninterrupted market supply throughout the entire change.
Referral procedure to harmonize product information
Led the harmonization of divergent product information across 9 EU markets as part of a PSUR-triggered Article 30 referral. Harmonized PI implemented on time in 8 of 9 markets; buffer time for national derogations was the deciding factor.
Climate Zone IVb market expansion without reformulation
Enabled expansion into Climate Zone IVb countries through a primary-packaging-based stability solution (PET bottle with desiccant) rather than a costly reformulation — the least demanding regulatory option, as no new stability studies were required.
Reformulation of an existing product — from concept to launch
Cross-functional reformulation program (R&D, CMC, RA, Supply Chain, Marketing) from concept phase to launch across 6 EU markets — 6 weeks ahead of target date, 8% under budget, no supply gap between old and new formulation.
Global marketing authorisation transfers following product acquisition
Transferred global marketing authorisations onto the new corporate structure following a product acquisition — including resolving MAH qualification in markets where the MAH must also be the manufacturing site. Completed including passed GMP inspections.
Current context
New Variations Guidelines and EU Pharma Reform
Since 15 January 2026, the new Variations Guidelines (C/2025/5045) apply: Type IA changes must be submitted as a bundled grouping within 12 months of implementation. For companies that need to align their RA processes with these new requirements, time-limited interim support is available — typically following a Diagnostic Sprint, and if needed continued seamlessly as a longer mandate.
Mandatory since 15 January 2026
Type IA changes that do not require immediate notification must be submitted within 12 months of implementation as an annual update, grouping or super-grouping.
Coming: database update instead of application
The Council-adopted reform text envisages database updates instead of formal applications for administrative changes — a system shift that will require RA processes to be rebuilt.
9 years of global authorisation management
Variations and renewals across EU, APAC, CIS, MEA and LATAM; dossier maintenance for Module 3.2.S and 3.2.P in the Global Core Dossier and German national authorisations at Viatris (MEDA Pharma GmbH & Co. KG).