Karsten Krueger
Managing Partner at MAIN5 | Frankfurt Rhine-Main Metropolitan Area
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Karsten Krueger, as Managing Partner at MAIN5 GmbH, brings a wealth of expertise in delivering strategic consulting and project leadership within the Life Science sector. His current role involves spearheading complex initiatives that require a deep understanding of regulatory compliance, document management, and informatics solutions tailored to the pharmaceutical and biotech industries. Karsten’s leadership is instrumental in guiding clients through the intricacies of regulatory requirements, including GAMP standards, registration tracking, and labeling compliance, ensuring that projects meet stringent industry standards while optimizing operational efficiency.
At MAIN5, Karsten oversees a diverse portfolio of key projects, ranging from interim management to large-scale change initiatives valued at over €1 million. His proven ability to mediate between business and IT functions allows him to develop innovative solutions that align regulatory affairs IT systems with overarching corporate strategies. His expertise in document management systems like Documentum, alongside proficiency in OPX2 and Planisware, enables him to streamline processes such as registration tracking and compliance documentation, ultimately reducing time-to-market for clients’ products.
Karsten’s international experience and open-minded approach foster a collaborative environment, essential for navigating the global regulatory landscape. His result-oriented mindset and commitment to added-value solutions position him as a trusted advisor for life sciences companies seeking to enhance their compliance frameworks, optimize informatics infrastructure, and implement robust change management strategies. Through his leadership at MAIN5, Karsten continues to drive measurable results, leveraging his extensive industry knowledge and technical skills to support clients in achieving sustainable growth and regulatory excellence.
Managing Partner at MAIN5 in September 2013 to Present
Subject Matter Expert / Industry Expert - Regulatory Affairs/Regulatory Operations at NNIT Switzerland AG in October 2010 to September 2013
Unit Manager Pharma R&D at Logica in April 2009 to October 2010
Head Global Regulatory Operations Coordination at Bayer Schering Pharma in August 1992 to January 2010
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Berlin University of Applied Sciences Berlin (BHT), Diplom, October 1988 to October 1992
Carl-Friedrich-von-Siemens Gymnasium, October 1979 to October 1987
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Regulatory Affairs
Document Management
Pharmaceutical Industry
Computer System Validation
21 CFR Part 11
Documentum
Validation
Project Management
Integration
Regulatory Requirements
Change Control
Outsourcing
Informatics
GxP
Regulatory Operations
eCTD
XML
Clinical Data Management
GAMP
SDLC
Data Migration
RIMS
Regulatory Affairs IT
submission management
registration tracking
EVMPD
xEVMPD
IDMP
MPDmanager
Labeling
PIM
Translation Management
SPL/PLR
Migration
SDLC management
submission planning
SOP management
Liquent Insight
CSC FirstDoc
OPX2/Planisware
Outtasking
submission content planning
eRegulations from Health Authorities
Pharma IT
Business Process Management
Business Process Improvement
Business Process Analysis
Business Process Mapping
Life Sciences
U.S. Title 21 CFR Part 11 Regulation
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Discover more about MAIN5What is Karsten Krueger email address?
Email Karsten Krueger at [email protected], [email protected] and [email protected]. This email is the most updated Karsten Krueger's email found in 2026.
What is Karsten Krueger phone number?
Karsten Krueger phone number is +491712918572.
How to contact Karsten Krueger?
To contact Karsten Krueger send an email to [email protected], [email protected] or [email protected]. If you want to call Karsten Krueger try calling on +491712918572. (updated on March 24, 2025)
What company does Karsten Krueger work for?
Karsten Krueger works for MAIN5
What is Karsten Krueger's role at MAIN5?
Karsten Krueger is Managing Partner
What industry does Karsten Krueger work in?
Karsten Krueger works in the Pharmaceuticals industry.
Karsten Krueger Email Addresses
Karsten Krueger Phone Numbers
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