GMP Consulting

100% compliance for all GMP and GxP areas

  • High practicability
  • Cost efficiency
  • Acceptance by representatives of the authorities
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Welcome to Experts Institut – Your GMP consulting experts for quality and compliance in the pharmaceutical, medical devices & life science industry !

At Experts Institut, we understand the critical importance of Good Manufacturing Practice (GMP) in the pharmaceutical industry. Our GMP consulting services are designed to ensure that your manufacturing processes meet the highest quality and compliance standards.

Our GMP consulting services at a glance:

  • GMP compliance review: Our experts conduct comprehensive reviews to ensure that your facility complies with GMP regulatory requirements.
  • Quality system optimization: We optimize your GMP quality system in terms of cost and compliance.
  • Interim mandates: Our experts support you as interim managers on a selective or permanent basis, depending on the task at hand.
  • Training and awareness-raising: Our range of services also includes GMP training and further training to qualify your staff and bring them up to date with current requirements and best practice.
  • Audits and inspections: Our experts carry out audits and inspections to qualify service providers and suppliers and also provide support in conducting internal audits. We also prepare your company for national and international official inspections.
  • Validation and qualification: In the area of qualification and validation, we create or optimize your overall strategy and support you in the planning, implementation and documentation of your validation and qualification tasks (including process validation, cleaning validation and computer system validation).

Your advantages

as a partner of Experts Institut

  • Optimal use of existing GMP resources

    We optimize your GMP compliance with your available options and adapt to your specific company context.

  • Our practical experience - your benefit

    Our many years of (inter)national practical experience will be to your advantage during official inspections and customer audits.

  • All-round GxP service

    Take advantage of our broad and holistic GxP portfolio: from training, GMP consulting and documentation support to technical consulting, audits and inspections, you will receive customized concepts and support from our team.

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We provide support with specialist expertise and many years of international project experience in all GMP-regulated industries (pharmaceutical products, medical products / medical devices, cosmetics GMP, food & nutrition), both in the commercial and development sectors (e.g. clinical trial medicinal products).

Our particular strengths lie in the provision of capable interim managers or management teams in the areas of QM, QA, validation/qualification and auditing. We support large companies as well as small and medium-sized enterprises.

Our employees come from former management and specialist functions in the pharmaceutical / life science industry, which enables us to offer very broad-based and technological support in combination with GMP compliance rules. From project manager to lead auditor, GMP expert to process/plant/clean room planner, we can respond to all our customers’ project requirements.

One of our “specialties” is the evaluation of existing and future GxP infrastructures and quality management processes through efficient audits/mock inspections.

GxP Consulting

We provide support with specialist expertise and many years of international project experience in all GMP-regulated industries (pharmaceutical products, medical products / medical devices, cosmetics GMP, food & nutrition), both in the commercial and development sectors (e.g. clinical trial medicinal products).

Our particular strengths lie in the provision of capable interim managers or management teams in the areas of QM, QA, validation/qualification and auditing. We support large companies as well as small and medium-sized enterprises.

Our employees come from former management and specialist functions in the pharmaceutical / life science industry, which enables us to offer very broad-based and technological support in combination with GMP compliance rules.

From project manager to lead auditor, GMP expert to process/plant/clean room planner, we can respond to all our customers’ project requirements. One of our “specialties” is the evaluation of existing and future GxP infrastructures and quality management processes through efficient audits/mock inspections.

What does cooperation with our experts look like?

Depending on your needs, we can work for you either on site or remotely, as well as in a hybrid model. Our experts either take the lead or integrate themselves into an existing project structure. In addition to support from individual Experts Institute employees, we also work for you in teams, which can consist of several consultants and interim managers. For the processing of individual tasks, we use either our own infrastructure or the infrastructure provided by you.

Why us?

Unlike other GxP consultancies, we are characterized by our special knowledge of international regulations and their interpretation, hands-on experience and our people skills in the area of coaching and GxP training. We provide GxP training not only for the industry but also for GxP-regulating institutions. With us, you have a holistic cooperation partner who coaches you sustainably and at eye level. Our aim is not only to complete the project in the best possible way, but also to ensure an effective transfer of know-how, e.g. in cooperation with our Experts Institute Academy. Using the example of the new Annex 1, we contribute our expertise in terms of feasibility and the necessary measures. Our guiding values are excellence in execution and loyalty to you as our client.

GMP / GXP services

GMP compliance check

At Experts Institut, we conduct comprehensive GMP compliance audits to ensure that your pharmaceutical manufacturing processes meet the highest quality and compliance & inspection standards and design. Our services in this area include

  • Detailed review: We review your manufacturing processes and the documentation of all GMP areas in detail (content and compliance).
  • Compliance report: We prepare a comprehensive compliance report containing the deficiencies identified and recommendations for appropriate and plausible remedial measures.
  • Processing of measures: We support you in the processing and implementation of the necessary measures (document creation or revision, technical review and input to GxP systems, creation of risk analyses, support for root-cause analyses, processing of backlogs, adaptation of approval-relevant documents, additional GxP training).

GxP support in the pharmaceutical quality system

An effective and fully documented quality system is crucial for product quality and GMP compliance. We serve both you as a customer of the pharmaceutical industry and small businesses including pharmacies. We support you in the planning and creation of your quality system as well as in the improvement and optimization of existing systems.

Our services in this area include

  • Individual systems and workstreams: Depending on the task at hand, we establish or revise sub-aspects and sub-processes of your pharmaceutical quality system, e.g. the system for process or cleaning validation or a system from the QM area, such as training or audit management.
  • Overall quality system: We check and optimize your quality system as a whole and in all GxP areas relevant to you (e.g. GMP system for the manufacture of IMPs, GMP system for the manufacture of biological active ingredients and medicinal products). We also establish complete GxP systems de novo depending on the regulatory dedication (active pharmaceutical ingredients and small molecules, biological active ingredients, mRNA and nucleic acids, finished medicinal product manufacturing [FDF], GxP system for sterile manufacturing including EU GMP Annex 1, GxP systems for solid, semi-solid and liquid forms). We also offer solutions for GMP exemption contexts and regulatory gray areas (reconstitutions).

Experts Institute

Added value

Security

Compliance and regulatory
Security

Increased efficiency

Im Rahmen von Qualität, Umsatz und
Kosten

State of the art

Erprobte und digitale Lösungen, auf der Höhe der Zeit für Ihren Erfolg

1 step ahead

Staying ahead of the competition and strategically

Training and sensitization

Training and sensitizing your team is crucial for compliance with GMP guidelines. At Experts Institut, we offer comprehensive training and awareness-raising services:

  • Individual training plans: We create individual training plans that are tailored to the specific requirements of your company.
  • Training materials: We provide training materials tailored to your GxP context, covering both your internal issues and the latest GMP guidelines and best practices.
  • Practical training: We offer hands-on training and workshops to ensure your team can effectively implement GMP requirements.
  • Certifications: We support your team in obtaining relevant certifications in the area of GMP.

Our training and awareness services aim to equip your team with the knowledge and skills to ensure GMP compliance.

WE ARE

  • Uncomplicated and solution-oriented
  • Sustainable and empathetic
  • digital and agile
  • working where and for what we are needed

WE WILL

  • Building excellence and passing it on to our customers
  • Deliver high-level results
  • Achieving compliance and efficiency

WE DELIVER

  • personal integrity
  • Customized and feasible solutions
  • Meeting at eye level
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Collaboration is that simple

Contact request

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Initial consultation

Get to know your contact person in a non-binding initial consultation

Briefing & offer

You will receive an individual offer based on your briefing

Strong partner

Rely on a strong partner at your side during your project

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Our expertise

Experts Institut Beratungs GmbH – Reliable solutions for long-term change

Business Solutions

GMP / GXP Consulting

Personnel consulting

EI Academy

Experts Institut – Your strong partner

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5 reasons for

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  • Compliance and regulatory security

  • Increased efficiency: quality, sales, costs

  • "State of the art" solutions

  • So that you are always one step ahead, we think strategically for you (first-mover advantage)

  • We take responsibility for decisions and results

Our motto

“We take responsibility and are there when we are needed”

<center>Christian<br/> Reinfelder</center>

Christian
Reinfelder

CEO
<center>Wolfgang<br/>Rudloff</center>

Wolfgang
Rudloff

CEO
<center>Dietmar <br/>Gross</center>

Dietmar
Gross

CEO
<center>Jessica <br/>Siefert</center>

Jessica
Siefert

CEO

Neustadt

Experts Institut Beratungs GmbH
Kirchwiesenstrasse 5

D-67434 Neustadt a. d. Weinstraße

Phone: +49 (0)6321 969210
E-mail: info@expertsinstitut.de

Fax: +49 (0)6321 9692199

Bamberg

Experts Institut Beratungs GmbH
Untere Sandstraße 53

D-96047 Bamberg

Phone: +49 (0)951 51939330
E-mail: info@expertsinstitut.de

Freiburg

Experts Institut Beratungs GmbH
Habsburgerstrasse 101a

D-79104 Freiburg im Breisgau

Phone: +49 (0)6321 9692120
E-mail: info@expertsinstitut.de

St. Gilgen (Austria)

Experts Institut Beratungs GmbH
Helenenstrasse 16

A-5340 St. Gilgen, Austria

Tel.: +43 (0)6227 21068
E-mail: info@expertsinstitut.de

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