How it works

How it works

Five stages from market-entry preparation to a local organisation. Specific approaches are proposed for each client.

Overview

The five stages

Main capability areas involved at each stage.

  1. START

    Market-entry preparation

    Clarify requirements and the business plan.

    • EU Market Entry
    • Regulatory
  2. CONNECT

    Specialists and partners

    Work with the European specialists each project needs.

    • Specialist Network
  3. BUILD

    Regulatory and business foundation

    Establish the regulatory, quality and clinical base in Europe.

    • Regulatory
    • Quality / QMS
    • Clinical & Evidence
  4. GROW

    Commercial and operational set-up

    Build sales, marketing and day-to-day operations.

    • Sales & Marketing
    • European Operations
  5. OWN

    Transition to a local organisation

    Prepare for operation by the client’s own European organisation.

    • Organization / Internalization

YOUR EUROPEAN BUSINESS Designed with the client’s own European organisation in view.

Approach

Our approach

  • 01

    Scoped to the situation

    Scope reflects the product, target markets, business plan and organisation.

  • 02

    Specialists across Europe

    Regulatory, quality, clinical, sales and marketing specialists are engaged as needed.

  • 03

    Internalisation in view

    Support is designed for future operation by the client’s own organisation.

FAQ

Can support start at any stage?

Yes. Companies with CE-marked products or existing partners start where their situation fits.

Is support limited to regulatory affairs?

No. Quality, clinical evidence, sales and marketing, operations and organisation are included.

How are approach and fees defined?

Proposals are prepared after understanding the product, markets and organisation.

Discuss where your organisation stands.

A short conversation is usually enough to identify the relevant capability areas.