Who this service is for
For Israeli affiliates, importers and manufacturers that need ongoing regulatory capacity, and international companies building their local operating model. Support can also cover an absence, a vacancy or a defined period of increased workload.
Deliverables we can agree with you
- A responsibility map covering your team, Medicalix, manufacturers and other service providers.
- A prioritized regulatory activity plan, including submissions, authority queries and portfolio deadlines.
- Dossier and correspondence coordination with global and local stakeholders.
- A documented handover, with open items, upcoming obligations and access to working records.
How the work progresses
Map the current position
Review the product portfolio, existing registrations, outstanding correspondence and the responsibilities already assigned.
Agree the operating model
Define the tasks to outsource, decision rights, reporting arrangements and any formal appointment requirements.
Maintain continuity
Coordinate routine work and escalation of open issues, with agreed updates to your internal team.
What to prepare for an initial conversation
Start with a non-confidential list of products, current registration status, upcoming deadlines, the support you need and the intended duration. Detailed dossiers and sensitive records can follow once appropriate arrangements are agreed.
Service scope
An Appointed Pharmacist role is agreed separately from general consulting and is subject to the applicable appointment requirements. It does not automatically include QP batch release, QPPV appointment or operational pharmacovigilance outsourcing.
Common questions
Can we outsource only part of our regulatory workload?
Yes. Medicalix can support defined activities alongside your internal team, or agree a broader ongoing scope. Responsibilities and handover arrangements are set at the start.
Can Medicalix provide interim Appointed Pharmacist support?
Interim support can be considered for leave, vacancies and transitions. The product scope, availability and formal appointment requirements must be assessed before the role begins.
How does regulatory outsourcing differ from a one-off consultation?
Outsourcing involves carrying out agreed activities over a project or ongoing period. A consultation addresses a particular question or decision. Medicalix offers both models.
Official sources
Consulted when preparing this page on 14 October 2026. Check the applicable current guidance before acting.