Architecting Scalable Innovation for the Global Life Sciences Ecosystem.

Bridging the gap between complex regulatory mandates and cutting-edge digital transformation. We build the frameworks that allow Top 10 Pharma and high-growth startups to lead, scale, and thrive.

Panel 1

Services

Architecting Scalable Innovation for the Global Life Sciences Ecosystem.

Bridging the gap between complex regulatory mandates and cutting-edge digital transformation. We build the frameworks that allow Top 10 Pharma and high-growth startups to lead, scale, and thrive.

Core Transformation Services

The Enterprise FrameworkThe Growth FrameworkThe Venture Framework
Optimizing Legacy SystemsScaling Operational MaturityRapid Turnaround & Exit Prep
AI/ML Integration & Data Governance Policies.Redesigning QMS frameworks to reduce development lifecycles by 31%.Interim CEO/COO leadership for business rescue and cultural shifts.
Global Clinical Trial system governance for 70,000+ users.Implementing lean governance and agile data analytics platforms.Transforming legacy consulting into scalable SaaS/RegTech products.
$700M+ Innovation Portfolio management with 10x ROI.“Workplace of the Future” remote programs saving $150M+.Driving 360% revenue growth to attract Venture Capital investment.
Panel 2

Profile

Stephan Klaschka, | Catalyst Executive | M.Sc., MBA, PMP, PSM

Stephan is an awarded strategy and transformation leader with more than 25 years of global work experience. He drives transformation, innovation, turnaround, and operational excellence in life-sciences companies of all sizes โ€” from startups to Global 20 enterprises in converging industries including Pharma, Biotech, Diagnostics, and Medical Devices with passion, integrity, and hands-on leadership.

His international executive positions included CEO, COO, CIO, Chief Growth Officer, Chief of Staff, Chief Innovation Officer, Chief Strategy Officer, Principal, and Regulatory Compliance Officer with extensive experience in entrepreneurship, start-up, academia, government, global corporations, and startups in various industries and geographies including Europe/Middle East/Africa (EMEA), the Americas, and Asia-Pacific (APAC).


Stephan Klaschka: From $700M Portfolios to $10M Project Rescues

  • A Proven Track Record: Over 25 years of global experience driving digital evolution, clinical operations excellence, and organizational effectiveness.
  • The HBR Standard: Featured as a thought leader in the Harvard Business Review teaching case “Boehringer Ingelheim: Leading Innovation,” utilized by business schools worldwide.
  • Regulatory Precision: Expert in navigating GxP, 21 CFR Part 11, and emerging AI/ML ethical governance to ensure innovation never compromises compliance.
  • Global Versatility: Executive leadership experience spanning the Americas, Europe, APAC, and LATAM.

Stephan holds three Master’s degrees in Computer Science, Management/Project Management, and Business Administration (MBA), and advanced degrees in Strategic Innovation, Entrepreneurship, Technology, and Leadership from leading schools in Europe and the United States.

He is a certified Project Management Professional (PMP), a Professional Scrum Master (PSM-I), and a graduate of the MIT Advanced Certificate for Executives (ACE) and IMD/MIT Entrepreneurship Development Program (EDP) programs.


Panel 3

Client Portfolio

Trusted by Global Leaders and Disruptive Startups:

Panel 4

Contact

Is your organization ready for the next level of maturity?

Stop managing symptoms and start building a framework for sustainable growth. Letโ€™s discuss how to align your technological roadmap with your clinical and commercial objectives.

Book a Consultation with Stephan Klaschka or send us an email at Contact@Klaschka.Co or:

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Klaschka & Co, LLC is registered in the State of New York, USA.