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QUALITY & ANALYTICAL SERVICES

Quality Systems for CDMO Projects

Do you want GMP-compliant drug development?  

At ProBioGen, we ensure pragmatic solutions tailored to your needs. Benefit from our holistic GMP-compliant quality system, our hands-on approach, and unwavering commitment to excellence. 

IN A NUTSHELL

Quality Systems to Ensure Regulatory Compliance

ProBioGen holds manufacturing licenses and GMP certificates for its manufacturing facilities. We see the challenges posed to our pharmaceutical quality system by regular health authority inspections and customer audits as an opportunity to continuously improve. Our focus is on a holistic approach to regulatory requirements for your product and service. 

Quality Systems
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mABs
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BsMABs
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Complex Recombinant
Proteins
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Fusion Proteins
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Cytokines
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Clotting Factors
HOW WE WORK

Fully GMP Compliant

As our quality assurance (QA) is involved from the beginning, all tasks, decisions, procedures e. g. follow quality standards and comply with GMP requirements.

Quality First

Our quality approach ensures that issues are identified and addressed quickly leading to transparent management of these challenges and finally better solutions.

Hands-on and Pragmatic

Our hands-on and pragmatic approach to quality questions ensures effective communication between you and the project team. You will get firsthand experience into how we work and how issues are managed. 

With a QP in Charge

Our in-house Qualified Person (QP) is responsible for certifying batches of drug substance for release and actively participates in tasks and projects. Accordingly, you benefit from short distances. 
How we work

How We Work in Our Quality Unit

Our QA Team

Our Quality Approach

Our Hands-on and Pragmatic Approach

Our In-house Qualified Person

OUR PROMISE TO YOU

Elevate your Molecule - in Time and Quality

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Rely on Fast Timelines
  • One-Stop-Shop with seamles, integrated Services
  • Parallel Processes
  • Efficient project execution
  • Do it right from the beginning
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Get Your High Quality Candidate
  • Scientific excellence
  • Deep understanding for molecule / Long + broad experience
  • Strong Analytics teams and stellar quality management services
  • Enabling technologies
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Have the Flexibility You Need
  • Modular Offering
  • Customer Centricity/ Strong Partnership Approach
  • Experienced Project Managers and efficient decision making
Quality Systems Principles

Our Quality Principles

ProBioGen complies with GMP requirements. Our pharmaceutical quality system incorporates appropriate risk management principles, including the use of applicable tools.  

QMS Certificates for our Herbert Bayer Str. facilities

QMS Certificates for our Goethe Str. facilities

Our Promise To You

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GMP-Compliant
  • For manufacturing and testing drug substances including stability studies 
  • For testing investigational but also commercial drug products 
  • For importing drug products for clinical trials in Europe
Team

Pragmatic and Competent QA Support
  • Guaranteed by our experienced and actively involved QA team 
  • Guided by an in-house Qualified Person



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Quality You Expect
  • From our QA team, which is actively involved in projects from the very beginning


     

Elevate Your Candidate With The Right CDMO

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