gempex – THE GMP-EXPERT turns 20

The team of the Managing Directors of gempex GmbH: (from left to right) Peter Bappert, Frank Studt, Ralf Gengenbach.

– An internationally recognized GMP expert headquartered in Mannheim, dedicated to product quality and patient safety
– Inspection Readiness for clients in the Life Sciences as a central outcome of the services
– Deeply rooted internationality: locations in Germany, China, and Switzerland
– From 15 to 80 employees in 20 years – gempex offers its over 80 staff long-term prospects, a varied field of tasks, and a family-like working atmosphere
– An engaged management team guides the company under specific focal points

An internationally recognized expert serving product quality and patient safety

In June 2002, a team of 15 colleagues set out to become THE GMP expert for the market. Today, 20 years later, this goal is within reach. The task constantly presents new challenges, which gempex will continue to face in the coming years.

GMP, Good Manufacturing Practice, aims to ensure product quality and thus guarantee safety for patients and consumers. gempex's clientele includes leading companies in the pharmaceutical, chemical, biotech, medical devices, cosmetics, logistics, and other players in the Life Sciences. In the area of "Good Practices" such as GMP, GDP, ISO 13485, and comparable quality assurance systems, gempex is recognized as an expert and supports the implementation of quality requirements worldwide.

"More than 80 employees, spread across several offices in three key, market-dominant countries, work for nearly all sectors of the Life Sciences industries, whether manufacturing or supply," says Ralf Gengenbach, founder and Managing Director of gempex. "This is a visible proof of a sustainable, well-established, and widely known company. Having a large team that is equally motivated and committed, acting responsibly and thoughtfully with the highest professional expertise – that is what makes our service unique. I am proud of that."

Quality, safety, trust – that’s what gempex stands for. And ultimately, it is the employees who carry this performance promise into the market and deliver reliably good and valuable work to each customer.

Inspection Readiness for Life Sciences clients as a central result of service quality

With high expertise comes a promise of performance to clients: Inspection Readiness. Because ensuring the quality of products, their production, storage, and distribution under Good Manufacturing Practice is regularly checked by the responsible authorities. For companies, it is crucial to pass these inspections, audits, or reviews efficiently and securely. Often, market access or manufacturing authorization depends on this.

For example, a company producing dietary supplements for the European and American markets faces multiple, sometimes differing requirements and must demonstrate compliance along specific guidelines. gempex supports here through national and international inspection preparation and accompaniment, individual coaching, group training, and especially by aligning company processes and facilities with regulatory requirements beforehand.

Inspection Readiness thus results from inherent compliance and targeted, expert preparation for the inspection itself. If the quality management system is securely implemented, all regulatory requirements are interpreted, established, and integrated into daily routines, a company is well-positioned regarding quality assurance.

Since gempex also conducts many audits on behalf of third parties, the colleagues understand exactly what matters in detail and how the situation appears from the perspective of regulatory authorities. Experienced auditors undertake the required review of suppliers worldwide – the ace up the sleeve of a GMP consultant.

Deep-rooted internationality: locations in Germany, China, and Switzerland

It was a logical continuation of successful business operations that led gempex to establish its own international locations. As early as 2005, the company operated directly from China, and in 2014, founded the subsidiary gempex China Ltd. With two locations in Guangzhou and Suzhou, local expertise and thorough knowledge of regulations are deployed.

Combined with GMP experts from Germany, gempex bridges cultures, languages, and knowledge of different GMP requirements, helping Western companies produce GMP-compliant in China or supporting Chinese contract manufacturers and suppliers in their partnerships with Western firms. As needed, gempex conducts 3rd party audits, gap analyses, and improvement programs.

Switzerland also plays a major role in the international pharmaceutical and medical market. Since 2008, gempex Switzerland, now based in Sisseln in the canton of Aargau, has been serving clients in Switzerland and nearby regions. The goal is to implement Swiss legislation requirements and their translation into practical Quality Life Cycle Management for highly regulated manufacturing according to the guidelines of the regulatory authority SWISSMEDIC.

An engaged management team guides the company with specific focal points

Over the years, a shared value system has been established at gempex, shaping the corporate culture. Core values include reliability and loyalty, openness and transparency, mutual appreciation, and creativity. In this spirit, the Managing Directors lead the company's paths, enable innovation, embed proven practices, and strategically steer new directions.

Ralf Gengenbach and Peter Bappert already have a shared history from the founding of gempex and have built the company together. Both are committed to the ongoing development and expansion of the service brand. Frank Studt strengthens the management team with responsibility for HR, marketing, and sales.

Each management team member focuses on a specific area, operating under an individual emphasis. On the company's website, they are introduced with the following quotes:

– Ralf Gengenbach: "My clients' challenges are my challenges. I approach them with particular care."
– Peter Bappert: "Individual tasks require individual solutions. Only then can goals be achieved efficiently and appropriately."
– Frank Studt: "Bringing customers and experts together, listening to people, understanding needs, finding the right fit – that’s how we shape the future. Sustainability is important to me in every respect."

This also includes supporting social initiatives and considering sustainability within business activities.

From 15 to 80 employees in 20 years – gempex offers its over 80 staff long-term prospects, a varied field of tasks, and a family-like working atmosphere

As a family-owned company, gempex has established itself over the years through financial stability, a strong order situation, and a unique market position. It offers long-term prospects, a diverse range of tasks, and a family-like working environment.

As an employer, gempex focuses on prospects, future, and job satisfaction. Because a profession with solid GMP expertise in the Life Sciences industry is a lifelong career. In two ways: not only the employees’ future but also the protection of users – patients and consumers – remains central when it comes to GMP and Good Manufacturing Practice.

Work-life balance is supported by structures such as flexible working hours, mobile work, and teamwork in dynamic groups. Based on a technical-scientific background, the company's experts support quality assurance projects in the pharmaceutical, biotech, chemical, or medical technology industries, ensuring the quality of products through the implementation of various national and international regulations.

The necessary expertise is continuously maintained through an internal, intensive training program. A positive working atmosphere, respectful interaction, and a workplace that is almost family-like despite professional expertise support the company's high problem-solving capacity.