Pharmaceuticals

Biotechnology and pharmaceutical complex

  • Effective solution
  • Long-term change
  • Industry-specific
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Your advantages

as a partner of Experts Institut

  • Sustainable structures

    Master all challenges at any time using the structures we have introduced.

  • Optimized processes

    Your advantage: save costs, increase efficiency, boost competitiveness, and much more.

  • Benefit from opportunities

    Take advantage of the digital transformation, strategy adjustments due to external influences.

  • Utilize full competence

    Successfully solve all specific problems such as sustainability and information security.

Successfully establishing long-term and sustainable changes

We establish sustainable structures in your company that you can continue to use for your success even after the order has been completed.

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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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GMP for pharma

As a key sector that is indispensable in the 21st century, the entire biotechnology and pharmaceutical complex has an important position for us. In decades of cooperation with pharmaceutical companies of various sizes, we have gained the best possible knowledge of the industry (in the areas of pharmaceuticals, active ingredients, excipients, cosmetics, medical devices) and can count these among our core competencies.

Experts Institut offers suitable solutions for all GMP tasks in the pharmaceutical industry, including GMP compliance consulting, GAP analysis, risk management, concept introduction or optimization, qualification of typical pharmaceutical equipment, validation of manufacturing and cleaning procedures, analytical methods and inspection preparation. A competent and experienced team of experts supports GMP tasks in all areas of pharmaceutical manufacturing, from pure consulting to the complete or partial handling of projects to personnel support in the context of on-site execution.

Selected service examples are offered, such as the manufacture and filling of sterile medicinal products, GMP compliance consulting with qualification after relocation, evaluation of qualification documentation and the qualification status of existing packaging lines, manufacture of blood plasma products, regulatory GMP compliance consulting and conversion of clean rooms for the manufacture of clinical trial products. GMP support includes the creation of specifications, design reviews, GMP risk analyses and supplier selection and qualification.

As the trust and confidentiality of customers are highly valued, we deliberately refrain from broadly naming customers. However, specific references will be provided if required.

GMP SERVICES FOR PHARMA & MEDICAL DEVICES

  • Introduction Quality Manual
  • GMP Quality Manual
  • Compliance
  • FDA Readiness
  • GMP, process and system audits
  • Process optimization
  • SOP and document management
  • Introduction Track Wise (Deviations, Complaints, Change Control …)
  • Strategic realignment
  • Information security management (ISO 27001)
  • Data Integrity & Computer System Validation (CSV)
  • Business Continuity Management (BS 25999)
  • Risk management
  • Introduction ISO 13485
  • CE product certification
  • Reorganization
  • Trainings and workshops
  • Deviation & CAPA Management

Our workflow

Kick off

Tell us about your specific request using our contact form and get to know us without obligation.

Determination of requirements

Your contact person will address your challenges and work with you to determine your requirements. This can be done online or on site.

Expertise

Benefit from our experienced consultants who will provide you with comprehensive and successful support for your project.

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Customer testimonials

What our customers think about us

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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
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