Skip to content
PharmExpert Consultant LLP
Market Access & Commercial

Local Agent Representation & MAH Support

Local agent / representative services and MAH support for liaising with authorities and registration.

Overview

Many markets require a local agent or representative to liaise with the authority and support registration and post-approval obligations — a legal prerequisite for market entry that companies without a local entity must solve. PharmExpert provides local agent representation and MAH support so you can register and maintain products where you have no local presence.

We act as, or arrange, the local agent and representative that the market requires, and liaise with the health authority on your behalf — handling the local interaction and submission logistics that a registration depends on.

Beyond registration, we support the ongoing MAH obligations attached to your authorizations, including variations, renewals and pharmacovigilance responsibilities, coordinated with our regulatory and PV pillars so nothing falls between functions.

We provide local regulatory and compliance representation and support onboarding and transitions when arrangements change. The result is compliant market entry and ongoing presence in geographies where establishing your own entity would be disproportionate.

What we do

  • Local agent / representative services
  • Liaison with health authorities
  • Registration support and submission liaison
  • MAH-obligation support (variations, renewals, PV)
  • Local regulatory and compliance representation
  • Onboarding and transition support

Our process

  1. 1

    Assess

    Determine local-agent / representation requirements.

  2. 2

    Establish

    Provide or arrange the local agent / representative.

  3. 3

    Liaise

    Interact with the authority and support registration.

  4. 4

    Maintain

    Support ongoing MAH obligations.

What you receive

  • Local agent / representative service
  • Authority liaison
  • Registration support
  • MAH-obligation maintenance

Who needs this

Companies registering in markets without a local entity, organizations needing authority liaison, and teams needing MAH obligations supported locally.

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.