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A CASE STUDY ABOUT A GROWTH-ORIENTED PHARMACEUTICAL COMPANY:

ORGANISATIONAL BUILD-UP AND STRATEGIC INTEGRATION OF MA'S

01 | The starting point

A European, mid-sized pharmaceutical company with ambitious growth targets acquired a large portfolio of Marketing Authorisations (MAs) from a global Big Pharma company.

The scale of the transfer was significant:

Approx. 400 SKUs
Annual revenue volume of approx. €300 million
MAs in 100 countries worldwide

To both set up a new legal and operational structure and transfer the acquired portfolio into this newly created framework, the company entrusted THE FORCE with a comprehensive mandate:

Starting with the establishment of regulatory foundations and preparing the IT landscape, the assignment further entailed finding, contracting, and integrating outsourcing partners, and finally delivering the operational implementation until organisational readiness was fully achieved.

Jump right to the results

02 | Impact of the problem

Tight timelines

to establish legal structures, secure pharmaceutical licenses, and complete inspections.

High regulatory complexity:

Global MAs across diverse jurisdictions increased the complexity of regulatory requirements.

Multi-stakeholder coordination:

The variety of stakeholders involved in the project required close coordination across, among others, CMOs, logistic providers, distributors and service providers in various fields.

Market interruptions:

Without a flawless MA transfer, there could have easily been disruptions in the market.

ERP process harmonisation

had to be carried out under strict GxP and documentation requirements.

03 | Our solution as THE FORCE

Close-up of a crane standing on a rock in a body of water. It has is wings slightly spread, almost giving the impression it's conducting.

Especially in complex scale-ups like this, clients need a partner who not only understands the requirements but takes responsibility until the final signature.

This is why this project was a showcase of what defines us as THE FORCE: We don’t just consult – we build real, functioning pharmaceutical structures with deep regulatory expertise, high information speed, and full execution ownership from start to finish.

Here, our approach translated to these measures in particular:

Close-up of a crane standing on a rock in a body of water. It has is wings slightly spread, almost giving the impression it's conducting.

Full development of regulatory infrastructure:

We applied for and established GMP and GDP licenses, while also developing the regulatory Quality Management System. Meanwhile, our team provided assistance during the preparation and performance of authority inspections and audits.

Legal & structural set-up:

To provide our client with an organisation able to hold and manage the MAs, we established the new legal and operational framework and filled the required regulatory roles (e.g. QP, QPPV, Information Officer, Graduated Plan Officer).

ERP system readiness:

When setting up the ERP system, we ensured that specifications and process designs were tailored to pharmaceutical compliance, while integrating both regulatory and logistical workflows into the ERP platform.

Outsourcing and supply chain:

Our experience in the industry allowed us to set up a GDP-compliant and flexible logistics network. As part of this, we took on the selection, qualification, and contracting of CMOs, 3PLs, and distribution partners in closest alignment with our customer.

MA integration plan:

To fulfil our client’s objective to seamlessly integrate existing MAs into a scalable operational model, we initiated the creation of the full integration plan.

04 | Results

The project was successfully delivered in two phases, after which a new organisational unit was both operational and sustainable, and a full governance handover had been carried out.

Phase 1: Foundation & set-up

approx. 6 months

Inlcuding key deliverables such as:

  • Set-up of a full regulatory infrastructure in record time (GMP, GDP, GTP licenses obtained)
  • All authority interactions and inspections successfully passed
  • QMS and SOP framework established

Phase 2: Implementation & integration

additional 6 months

Inlcuding key deliverables such as:

  • Complete ERP-readiness achieved
  • External supply chain and manufacturing partners qualified and onboarded
  • Go-live of the new structure with €300 million revenue potential secured
  • ~400 SKUs transferred across 100 countries, fully compliant

During both phases, we provided the core resources and leadership to guarantee speed, precision, and regulatory compliance. In parallel, we helped to develop the client’s internal organisation through guidance and support from our experts as well as by filling interim roles.

05 | Strategies for continued success

Ongoing guidance:

During the next step of integrating the existing business into the built-up operation model, we’ll continue to support and provide guidance to our client.

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Business integration:

The creation and execution of the MA integration involves a structured transfer of approx. 400 SKUs into the new legal entity across global markets. It also extends to establishing new supply chains by performing the required RFQs, contract preparation, and tech transfers accompanied by our regulatory team to achieve the necessary approvals.

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