Yasmine Peters, MD, Marco Glauner, MD and Beate Krüger, MD
Marco Glauner, one of the three managing partners of prime4services prides himself on knowing which way the wind blows. In his “not so often” free time, Marco—an avid sailor—can be seen working on his 50-year-old wooden boat to prep her up for setting the sails for the maiden voyage. “Driving a boat is a matter of precision and responsibility,” he says while adjusting the masts of his boat. “There are a lot of aspects that you have to keep in mind and manage: the force, the direction of the wind, and the water’s strength which is quite similar to running a business successfully.” And truly so, as a global consulting and engineering services provider, prime4services—co-founded by Marco—has been successfully supporting the life sciences industry by adjusting and evolving with the changing customer needs and the progression of trends over the times of third and into the current fourth industrial revolution. With offices across Europe and Asia, prime4services has worked with many of the Global Fortune 500 companies.
Started by Marco and his two co-founders and managing partners—Beate Krüger and Yasmine Peters—nine years ago with the idea of operating as a manufacturing execution system (MES) as well as Track and Trace consultant and service provider for pharmaceutical companies, prime4services has evolved multifold since then. “At one point of time, we started looking deeper into providing MES services for the pharma industry, and soon transitioned into a consulting and implementation partner for different kinds of systems,” he says. Through programs and projects that the company delivered on the end-user side, Marco and his partners started learning about different business processes and about taking methodology-based approaches, which has become a key differentiator for prime4services today. “We leveraged our knowledge in the industry to evaluate the options and conceptualized a true service company,” states Marco, “the key driver has to be processes and the business cases, the technology like an MES is just the tool that has to be adapted to it”. They are now a team of 40+ experts who specialize in MES, T&T, OEE, LIMS, Validation, project and program management, and e-compliance areas, moving all those elements into the world of Industry 4.0 now. By the time the company was fully operational, it had started to target a niche sector of the life science industry, specifically around documentation, regulations, and business processes. Covering both the know-how and consultancy aspects at the same time, the company has been successful in digitalizing the pharmaceutical industry.
Evolving with the Industry
In 2015, the pharmaceutical industry touched a milestone with the first 3D printed pill.
Understanding the customer’s challenges at a very early stage of the project allows us to identify and implement the right solution
When industry experts predict that in ten years, pharmacies and hospitals would start printing the pills they need, they are merely hinting the transformation the pharmaceutical industry will attain in the coming years. Further, with the recent push by Industry 4.0, the process of production management in the life sciences sector has become an important topic of discussion for global customers, suppliers, and consulting companies alike. When it comes to that, issues related to policy reforms in the strictly regulated healthcare compliance industry will bring uncertainty in the market. Mandates regarding product quality and patient safety and guidelines to be followed during documentation, etc., remain as prime pain points for the major players in the industry. With ears to the ground, prime4services has been matching every step that the pharmaceutical space takes. By leveraging their experience in the industry, prime4services has developed the so-called SMARTT packages and tools for typical scenarios—including Return-on-Investment assessment, process analysis, site readiness assessment, etc.,—that most customers face during project implementation. The company acts as an independent service provider to manage its clients’ relationship with every technology supplier that exists in their ecosystem.
Over the years, prime4services has successfully operationalized software implementations, which include classical MES products of companies such as Rockwell Automation, Werum, Siemens, Emerson and AspenTech, and also SAP’s PI-Sheets with XSteps. With its agile and innovative approach, prime4services ensures that an optimal and efficient implementation of the project is undertaken. Their methodology-based approach brings together processes, technologies, and people leading to a solution that makes optimal use of their client’s existing /new systems and resources— all the time staying completely neutral and vendor-independent.
What really differentiates prime4services is their relentless and singular focus on the regulated pharmaceutical industry and their proficiency in leveraging a methodology-based approach. This empowers their clients with a high-level of process and business understanding. prime4services goes one step ahead of its competitors by simulating the use case scenarios for a client, which enables them to define the real needs for MES and thereby deriving the actual benefits of the use of such system.
The Spotlight on Compliance
As regulatory compliance management is complex and comprehensive, the company identifies potential threats to overcome this issue during the project-planning phase. “Understanding the customer’s challenges at a very early stage of the project allows us to suggest and implement the right solution,” says Marco.
From evaluating the right software for its clients based on actual use cases to planning and deploying the entire project with all its engineering and validation aspects that are needed around a selected MES supplier, prime4services delivers its services expertise throughout the complete lifecycle of an MES project. Knowledge transfer is done through Go-Live and as the company calls it, the “hypercare” phase to support their clients’ ongoing operations. In addition, prime4services also derives insights from similar projects that they undertook previously, to identify threats concerning regulatory compliance. Marco reminds that patient safety is guaranteed through a commitment toward quality and compliance.
"We are a pure service based, process oriented and project-driven company, and will always be perceptive to our customers’ needs, and grow organically"
The company realizes the significance of documenting the manufacturing process for future references in case of an unexpected event leading to a compliance threat. With the regulators constantly broadening the requirements for compliance, prime4services follows a specific methodology that mitigates the complexities of regulatory compliance management.
A Pure Service-Oriented Company
Though drug manufacturers are fundamentally aware of regulations, they tend to focus on acquiring only the technical expertise, and often, regulatory compliance gets sidelined. prime4services’ mission is to bring back compliance topics to the spotlight again, by preparing the manufacturer in clearing the approval by the health department. The company is also engaged in training and providing operational support to their customers after the project handover. These include training on processes, change management, compliance regulations, etc.
Referring to a use case, Marco elaborates the success story of a multinational pharmaceutical enterprise, which had acquired a new site. For enabling the continuity and supply of products into the market, the client had to speed up the acquisition. Meanwhile, the client had to replace the existing MES and ERP system till formal completion of the acquisition, for full integration with the new mother enterprise. Being faced with this challenge, prime4services segmented the overall project into various independent work streams, supervised the entire project by employing an overall project manager who in turn ensured that the work streams moved at the same pace, also managing dependencies between them. By involving a higher number of workforce, implementing the SMARTT packages, and also identifying threats at a very early stage of the project through stringent risk management process, prime4services handed over the project on time and within the original budget.
Headquartered in Germany, prime4services’ global employees drive its future forward, making sure that the firm is far ahead in terms of innovation and market reach. The company also stays away from integrator partnerships with vendors, as it affects not only the trust but also neutral execution of vendor evaluation. Operating as a 40+ experts team, prime4services has plans to double their workforce in the near future. “We are a pure service based, process oriented and project-driven company and will always be perceptive to our customers’ needs and grow organically,” he concludes.