20 years gempex | gempex - THE GMP-EXPERT

gempex is 20!

The excitement is high when you found a company. Where the journey leads and its success remain uncertain. You are highly motivated, confident in yourself and your idea, ready to do whatever it takes to reach far-off and ambitious goals.

But it’s not always easy. The journey is marked by success as well as failures. On the way, you soon learn that having the right goal is important, but those who accompany you on the journey matter even more.

The goal – being the GMP expert – turned out to be the right one on our journey, albeit very challenging as well. Quality, reliability, ongoing learning, openness to new things – these values have defined the gempex journey, associating the company’s name with those attributes in the market. Yet quality does not mean freedom from mistakes. Like the maintenance of a ship on its journey, identifying, admitting and eliminating mistakes translates into ongoing upkeep and improvement.

However, the best goal is of little use unless you have people on board striving for the same goal, with equal motivation and dedication. Employees and also our customers have been part of the long and successful journey that defined gempex as a trademark. More than 80 GMP experts, distributed over several offices in three key countries that define the market, working for nearly all sectors of the life sciences industry, from manufacturing to supply, bear witness to a lasting, now well established and widely known enterprise.

I would like to thank everyone – customers, friends, business partners and especially all employees – who made this success happen!

Have we reached our goal, finished our journey? By no means! The goal has become more tangible, we are closer to it, yet it continues to pose new challenges. Over the coming years, gempex will rise to these challenges and I appreciate everyone who will be part of this ongoing, exciting and turbulent journey.

With kind regards
Ralf Gengenbach
Founder and Managing Director
gempex GmbH - THE GMP-EXPERT

Key Points in the Company’s Development – From the Life of gempex in the Past to the Current Day

A lot has happened at gempex in 20 years. A selection of key points that defined the company’s development is presented here.

You are invited to take a look.
Enjoy!

2002 - Foundation of gempex GmbH

In June 2002, gempex is founded. A team of 15 experts gathers with the goal of being THE GMP EXPERT for the market. Much later, the goal is actually written down just like that.

Mission:
"gempex is the GMP expert, a German service provider for the life science industry with an international orientation.
We develop solutions tailored to meet requirements, based on the value chain of our customers and in compliance with legal standards for the benefit of society. We keep our expert knowledge up to date, make complex issues comprehensible and serve as a strategic, visionary partner.

What is the guiding principle here?
"As the GMP expert, we offer the knowledge, provide the customer with the necessary knowledge, experience, reliability and guarantee for our customers. That is what gempex has committed to and anchored in its mission statement. Customer satisfaction always plays the central role."

By ensuring product quality, we contribute to value creation by our customers and offer a measurable benefit. That is our greatest ambition.

The following basic conditions shape the understanding of values: reliability and loyalty, openness and transparency, mutual esteem, creativity.

2003 - Company Management of the First Hour

Ralf Gengenbach and Peter Bappert looked back on a shared history when the company was founded and built it up together. They have been working together since 1997. The two share a commitment to the further development and expansion of the service brand.

Ralf Gengenbach:
"The challenges of my customer are my challenges. I therefore approach them with special care."

Peter Bappert:
“Individual problems demand individual solutions. Only then can goals be reached efficiently and requirements met.”

2004 – The Good Old Homepage

Long-standing partners and friends of gempex will surely remember this Internet presence, the first gempex homepage. It said everything there was to be said about the scope of performance for GMP, audits and quality assurance systems. It answered every question that could be asked about the company.

And it was downright legendary! Probably because it remained live until 2016 as the world’s last HTML company website – it was, quite simply, good.

2005 – 100% Growth for gempex ...

After just three years, the number of employees has doubled, exceeding 30 for the first time. At the same time, the largest and longest foreign gempex project in South Korea, “Vitamin B2”, is brought to a successful end.

What follows? A new home for gempex! In Mannheim, the technical office moves from the Floßwörthstraße to Besselstraße 6. Not even 5 minutes away, but with lots of potential for further growth!

Progress is made on the international stage as well: The first gempex activities in Switzerland begin...

... and the Company Gets Established in China

The joint venture “gemro Services Ltd” is founded in China as the precursor to gempex China.

gemro bundles the strengths of gempex GmbH and He-Ro Chemicals Ltd., supporting companies in the chemicals and pharmaceuticals industry with the implementation of quality requirements according to GLP, cGMP, ICH Q7A GMP, ISO 9000 and others.

The company’s registered office is in Hong Kong but it operates from an office in Guangzhou. The name quickly becomes known throughout China since GMP is absolutely a hot topic at that time.

Nine years later, gempex China ultimately starts out with a wealth of experience, since many team members stay on board. Local know-how, international expertise, established and practical knowledge of regulations.

2006 – Quality Management, also for Qualification – Initial DIN EN ISO 9001 Certification

“Working according to quality standards is essential in order to offer quality.” Sounds logical. Quality and efficiency are very important to gempex, for example, in qualification on behalf of customers. Which is why gempex defines and documents standards for the delivery of its own services and establishes an internal quality management system.

Initial certification according to DIN EN ISO 9001 was successfully obtained in 2006. Since then, gempex has been quality certified continuously and with highlighted positive aspects – frequently knowledge management, training planning and onboarding.

That is a good fit for the company’s central vision:
“With professionalism and enthusiasm, we promote success and quality assurance for products related to health and life.”

2007 – 5 Years of gempex

Woohoo – off to a good start and everything went smoothly.

Reason to celebrate! A cosy celebration, with all employees in a familiar atmosphere. Outdoors, at the new company headquarters on the Besselstraße in Mannheim. A small hut to sit and chat has stood in the spot ever since. A well-considered location, great for sunny lunch breaks in summer.

There is much to coordinate, much to develop together. The large conference room in the technical office is used for meetings. It is still sufficient for company meetings, regularly attended by all colleagues with active participation.

2008 – Greetings from the Switzerland Location

GMP expertise from the neighbouring country – gempex opens the branch in Switzerland. First in Laufenburg, with later relocation to Sisseln.

Customers in Switzerland and the border regions are served from here. Basel, home to many big players in the pharmaceuticals industry, is not far. Neither is gempex. Thanks to local employees, the company is intimately familiar with the specific requirements of Swiss laws and their implementation in practical quality life cycle management.

Swiss companies benefit from the full range of services offered by gempex. GMP for cannabis is a topic in particularly high demand in our day.

2009 – The Work Goes on. Growth Continues. Things Are on the Horizon.

In the confounded seventh year, the work just goes on. gempex establishes itself in the industry and gains recognition as the GMP expert with international expertise.

The first long-term partnerships are on the horizon. gempex becomes the lead consultant for customers in the pharmaceuticals and chemicals industry, providing ongoing support for GMP, GDP and cGMP matters with technical know-how and a broad process understanding. Cooperation based on trust.

gempex offers individually tailored services. GMP experts provide concrete, project-focused support or work directly on site for the customer in the Quality department – Onsite Execution. The team maintains close contact. Open communication and regular meetings and excursions are important.

2010 - Quality Network and Reputation

The VIP 3000, Verein Interessengemeinschaft Pharmabau 3000 e.V., develops visions for pharmaceutical construction and clean rooms. Objective: Effectively assuring and improving the quality of pharmaceutical production over the long term. Ralf Gengenbach is the association’s president.

gempex establishes and maintains contacts in the professional world. Knowing the right technical experts and contact persons, close networking, collaborating as panel members, continuously developing expert knowledge. Offering optimised solutions to customers on this basis in terms of procedures and implementation.

That becomes the gempex expert recipe for success, laying the foundation for the excellent (and well-earned) reputation in the international GMP world.

2012 – gempex Celebrates 10 and Exceeds 50

10 years have flown by. Wow!

More than 50 people are proud of this – that is how large the circle of colleagues has become. They celebrate with a big party in the VIP pavilion at the Luisenpark in Mannheim. Many of you probably remember, especially the beautiful event program?

2014 – Internationalisation Continues with a Bridge to China

In 2014, gempex China Ltd. goes live as a wholly-owned subsidiary of gempex GmbH. Local know-how directly in China, on site in Guangzhou.

This is where gempex together with the GMP experts from Germany builds a bridge, converging the culture, language and knowledge of various GMP requirements. Helps western companies with GMP- production in China. Provides support to make Chinese job-order manufacturers and suppliers fit for their partnership with western companies. Conducts 3rd-party audits, gap analyses and improvement programs as needed.

2016 – Welcome to gempex – THE GMP-EXPERT

On the new website, gempex shows its colours. With a fresh look and new grouping of the services, gempex offers what gempex has always offered:
GMP – Consulting & Execution.

The services offered by gempex encompass GMP Compliance, Commissioning & Qualification, IT Validation and GMP Routine Support. Depending on the tasks and the personal requirements, support is provided in the following forms:
Consultancy, Project Execution, Onsite Execution.

Quality. Guarantee. Trust.
Everything stays the same. It just looks different.

2017 - Principals and Inspection Readiness

Due to consistently high demand for GMP compliance services at the highest level, gempex establishes and expands the team of “Principals”. That’s what the Principal Consultants at gempex are called: Colleagues with the most extensive expertise, for example, based on many years of industry, sector or also government agency experience. gempex offers outstanding projects and a great deal of freedom as enticements. This is well received. Who wants to join the team?

Inspection readiness is the service proposition that goes along with that. This is what gempex does so customers can calm themselves and relax. gempex offers full service, from the initial consultation to obtaining the production license or successfully passing the inspection or audit. Nationally and internationally.

By the way: Third-Party Audits are another service increasingly provided by this experienced team. Certified auditors on board! The demand for this service grows rapidly around the world.

2018 - Half the Night and More ...

For a good cause, gempex gets things moving! In particular, some employees themselves – between 25 and 50 kilometres, one even up to 100 kilometres! An unflinching team of gempex colleagues spends half the night and more running around Frankfurt. A running event – not the first, nor the last. “As far as your feet will carry you” has its original meaning here.

Social responsibility is an important topic. For example, gempex supports the Deutsche Kinderkrebshilfe association, funds German and SME scholarships, and is an active member of various university booster clubs.

Another good cause: Sustainability and resource conservation. gempex puts a greater emphasis on relevant environmental protection aspects. A reduction of business trips, a view to climate neutrality, the digital transfer of relevant facts and knowledge – the range of activities is broad here as well.

2019 – Expansion of Company Management

gempex is growing. And wants to keep growing.

Therefore, company management does as well. Frank Studt strengthens the gempex management team with responsibility for Human Resources, Marketing & Sales.

Frank Studt:
“Bringing customers and experts together, listening to people, understanding needs, finding what fits – that is the way to a successful future.”

2020 – GMP Experts with a Passion

A company with a future and familiar workplace atmosphere is seeking new colleagues (f/m/d). Professionals and Young Professionals. GMP expertise and specialised know-how are acquired through the extensive training programme and directly from mentors in the course of onboarding.

Working at gempex is meant to be enjoyable. gempex promotes teamwork, planned onboarding, communication as equals, flexible working hours, mobile work, freedom and fascinating tasks.
“We are GMP experts with a passion – and you can be, too!”

That is the claim of the gempex employer presentation. More of that on the career page, along with current job postings offers.

2021 - ECA Validation Group and ...

gempex has “always” contributed actively to the design and harmonisation of GMP regulations.

Dedicated to efficient qualification, gempex reviews specifications and guidelines, realises synergies, and saves customers time and money.
Ralf Gengenbach becomes Chair of the ECA Validation Group in 2021.

... gempex China in Suzhou

gempex China opens a new location. In Suzhou, Jiangsu, China. Rapid availability is an important factor, especially in the GMP-regulated environment. With the second site, gempex China moves even closer to the centres of the pharmaceuticals and biotechnology industry.

不仅中国客户受益于gempex中国的本土化和存在，而且欧洲客户也希望通过gempex德国或gempex瑞士迈向亚洲。

PS:
That translates to: Not only Chinese customers benefit from the local proximity and presence of gempex China; European companies who want to take the step to Asia with gempex Germany or gempex Switzerland do as well.

2022 – gempex Turns 20!

A major event!

Thank you to all partners, customers, friends, companions, and most of all the employees of gempex. All of them have made this success happen.

For the 20-year company anniversary, gempex wishes you all the best!

Successful, exciting, healthy and also good times.
We look forward to what’s coming.

... and is Fit for the Future!

The course is set. Much is clear, some remains to be seen. Who knows what will enrich the gempex journey. Ambitious goals for the company’s future over the short and medium term have been defined and are being tackled.

gempex is growing! And remains the development leader for GMP and regulations. When it comes to helping customers with their challenges, assuming tasks and realising inspection-ready plants, gempex is always there with enthusiasm.

We are heading into an exciting new era!

You Have Something to Tell us?

Please write to the gempex team. We would love to hear from you!

online@gempex.com

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