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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. 

ProBioGen Quality System Services
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. 
Quality Principles-01

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

Asset 11
 
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
Asset 4

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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