A CASE STUDY OF GROWTH & COMPLIANCE:
TRANSFORMING A BUSINESS INTO A PHARMACEUTICAL WHOLESALER
01 | The starting point: Our client in 2018
Origin:
European branch:
Specialisation #1
Specialisation #2
02 | The beginnings: Not yet a pharmaceutical company
Only a physical office
Limited staff
Limited internal knowledge
The goal: Set-up of a robust Quality Management System (QMS) to enable the company's registration at the local competent authority as a wholesaler
03 | Impact of the problem
Critical gaps in regulatory knowledge + lack of established QMS
Absence of qualified personnel in key quality roles
Operational inefficiencies
All of these factors resulted in the necessity of full reliance on external support to establish compliant operations – which we provided with our services.
Without support from THE FORCE, the client would have faced delays, increased costs, and missed commercial opportunities.
04 | Our solution as THE FORCE
Providing Quality personnel and assuring key functions
From the beginning of the project, we provided the necessary Quality personnel to our client – and still continue to do so 7 years later.
This allowed the entity to remain slim and agile, and the company to focus on their commercial activities.
Assistance with critical tasks during start-up phase
Our team provided a range of cricital tasks, including:
Implementation of a streamlined QMS
Implementing a streamlined QMS was crucial so it could be effectively managed by a small team.
The solution focused on optimising processes to ensure compliance with regulatory standards while maintaining operational efficiency.
Structuring key processes to be simple yet effective
In all of this, we took care of the processes that allowed our client to focus their time and energy on their commercial growth.
Providing additional capacities on demand
Providing additional capacities only when necessary, without overwhelming the organisation, gave the company the opportunity to operationalise their business model in short timelines.
05 | Results
We enabled the company to operationalise their business model, and then supported the transformation of said business model at a later stage as desired by the customer – all while ensuring the company's scalability.
As a result, the client achieved strong business performance shortly after the initial setup phase end experienced rapid development.
06 | Strategies for continued success
To ensure continued growth and success, the company is proceeding with its development by implementing, amongst other things, the following steps:
Continued provision of key functions by THE FORCE
Transformation of QMS to act as MAH
One of the next steps for the company includes the transformation of their QMS in 2024 to enable them to act as a Marketing Authorisation Holder (MAH).
This is achieved through the implementation of a Pharmacovigilance system and registration with the local authorities.
Expanding operations as a wholesaler of finished dosage forms
Launch of first formulation
Moving forward, these advances will further strengthen the company's position in the pharmaceutical market, while a continued partnership with THE FORCE supports the ongoing optimisation, regulatory compliance, and sustained success.
