MA Licensing & MA Holding
Marketing authorization licensing support and MA-holder services for companies without a local legal entity.
Overview
Holding a marketing authorization carries real legal, regulatory and pharmacovigilance obligations — and not every company has a local entity to carry them in every market. PharmExpert supports MA licensing and provides MA-holder services so you can register and market products in target geographies compliantly, without standing up a local company everywhere.
We support in- and out-licensing of authorizations, including the regulatory transfer mechanics, and act as or arrange the MA holder where local rules permit. Structuring the arrangement correctly is essential, because the holder bears defined responsibilities that cannot simply be assumed away.
Holding an authorization means maintaining it: variations, renewals, and the pharmacovigilance and QP obligations attached to it. We coordinate these — including QPPV and PV responsibilities through our pharmacovigilance pillar — so the full set of holder obligations is reliably met.
We provide compliance oversight of the held authorizations and support transitions and onboarding when authorizations move. The result is market presence and a compliant MA-holder structure in geographies where you have no entity of your own.
What we do
- MA licensing (in/out) support and transfer
- MA-holder / local-representative services where permitted
- Maintenance of MA obligations (variations, renewals, PV)
- Coordination of QP and PV responsibilities
- Regulatory compliance oversight of held authorizations
- Transition and onboarding support
Our process
- 1
Assess
Review the products, markets and MA obligations.
- 2
Structure
Define the licensing / holding arrangement.
- 3
Hold
Carry or arrange MA-holder obligations.
- 4
Maintain
Keep authorizations compliant across the lifecycle.
What you receive
- MA licensing / transfer support
- MA-holder service arrangement
- Obligation-maintenance plan
- Compliance oversight reporting
Who needs this
Companies entering markets without a local entity, organizations in/out-licensing authorizations, and teams needing MA-holder obligations managed.
Frequently asked questions
Ready to improve your compliance?
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.