Mónica Unger-Bady

Expert for regulatory compliance

CONELIS expert Mónica Unger-Bady

Managing Director, Unger-Bady Consulting & Services


German, English

Services offered within Europe


Contact Me

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Call me: +49 (0)30 20275770


 Practical Experience

  • Audit Regulatory Affairs
  • Provide practical experience for regulatory compliance
  • Develop regulatory strategy for expansive variations

Reliable Data

  • Develop and project databases for Regulatory Affairs
  • Develop, implement and train workflows to generate high quality regulatory data 

Risk assessment

  • Risk-management for regulatory compliance
  • Workflows

  • Develop and implement workflows, interfaces and standard operation procedures for regulatory compliance
  • Mediate between Regulatory Affairs and Production services
  • Develop processes for interaction between Regulatory Affairs and Research & Development

Coaching and Training

  • Coach executives especially for implementing new workflows
  • Provide specifically tailored in-house workshops for regulatory compliance

About me

My strategy is based on…

  • … a high level of competence from considerable hands-on experience.
  • ...  extensive knowledge of the regulatory and product supply environment in an international pharmaceutical company.
  • … commitment to straightforward and highly efficient workflows.
  • … satisfying the employees within your organization.
  • … dedication to regulatory compliance.

My profile

  • Executive manager, consultant and coach for Regulatory Affairs in pharmaceutical industry
  • Profound professional knowledge with regard to interdisciplinary and global workflows / organizations especially in Regulatory Affairs and Regulatory Compliance as well as the development and implementation of involved IT-solutions.
  • Powerful, stringent and cooperative leadership aligned with conceptional thinking and assertiveness as well as sure instincts for politically correct and perceptive implementation of projects were prerequisites of the current success.



  • Pharmacist
  • Expert in Regulatory Compliance
  • Systemic Interactive Coach

Areas of Expertise

  • CMC
  • Regulatory Affairs
  • Interdisciplinary overview

Success stories