• Design of an integrated CMC development plan addressing the strategic
    and technical aspects of chemical and pharmaceutical development

API development

  • Physicochemical characterization and structure elucidation
  • Sourcing of starting materials, intermediates and API
  • Upscaling and GMP synthesis
  • Chemical process development - from QbD to Process Validation [ICH Q11]
  • Stability study design and evaluation

Formulation development

  • Preformulation development
  • Formulation development according to ICH Q8 QbD using DoEs
  • Supply of medication for pivotal preclinical studies
  • Packaging labeling of IMP and supply for international clinical trials using IRS according to GDP requirements

Analytical development

  • Analytical methods development and validation for drug substance and drug product
  • Process Analytical Technology (PAT)

Process development

  • Upscaling and GMP production
  • Manufacturing process development and launch of a QbD process [ICH Q8]
  • Process validation and post approval change management
  • Stability study design and evaluation
  • CMO and CRO selection and management

CMC regulatory affairs

  • Determine the relevant CMC regulatory strategy and assure the quality, consistency and technical validity of CMC regulatory documentation
  • Preparation of and attendance at meetings with regulatory agencies
  • Compilation of IMPD / IND for international Clinical Trial Applications Phase I - III
  • Compilation of Dossier Module 3 for MAA/NRA to FDA, EMA, ANVISA, WHO Article 58
  • Evaluation of CMC documentation for due diligences

Quality assurance management

  • Quality Assurance strategy and regulatory compliance for development projects
  • Set up and maintain the Quality Management System
  • Quality Risk Management [ICHQ9]
  • Compilation of quality assurance agreements
  • Deviation and Change Control Management
  • Qualification of external supplier including conduction of 3rd party audits of CMOs, and analytical labs
  • Preparation for FDA and EMA inspection and conduction of pre-site inspections
  • Participation on audits by regulatory authorities (local and FDA)
There are a range of questions to be addressed for drug development projects.
  • According to which criteria projects are likely to be successful?
  • How can time to market be optimised?
  • How can drug development be organised effectively?
  • How can wasted expenditure on projects be avoided?
Good strategies can be found by understanding the inherent risks in development projects, when these risks are encountered, and how sensible risk-management strategies can be implemented.
I have gained strong capabilities in project management holding leading positions which involved close interaction with external CMO’s and CRO’s, internal multi-disciplinary drug development team members and management.

My key services in project management include:
  • Compilation of project plan (specify strategic project goals and operational deliverables, define project risks and mitigation approachs)
  • Monitoring of pharmaceutical development within the drug development project and integrate the deliverables of the CMC development plan with the objectives of the drug development program
  • Ensure that project milestones will be reached in time within defined specification and budget
  • Primary technical and project point of contact for supplier and internal organisation
  • Set and improve project quality standards in relation to technical and pharmaceutical requirements
Interim management is the temporary provision of management resources and skills. In a short-term assignment for a certain project or a defined time period I will manage a transition period, crisis or change within your organization or provide a specialist expertise. Due to my experience and expertise I will conduct and complete assignments effectively and with a hands-on approach. I have the essential ability to rapidly merge into an organization and use this close integration to assume operative responsibility.

Based on my expertise I am able to take over e.g.
  • Project management functions
  • Head of Formulation Development
  • Head of Production according to § 12 AMWHV [German Drug and Drug Substance Act]
  • Head of IMP Manufacturing
  • Head of Pharmaceutical Development
  • Head of Analytical Development
  • Regulatory Affairs Manager
  • QA Manager
Systemic business coaching looks at the individual management executive or team member as a part of a complex system. It is all about the interaction of the acting people in the system. Systemic business coaching enables to recognise and use strengths and weaknesses, to gain a comprehensive overview over the current situation and subsequently to develop and implement concrete solution strategies.

Change Management

Nowadays whole organization, its individual units and members have to adapt to the fast changing economic and political dynamics. The sooner, the more jointly and the more proactively changes can be performed, the better. I will lead you through organisational changes processes with the goal of maximizing benefits and minimizing negative impact and to generate a balanced system.

Leadership Coaching

Together we will define important goals for you and your team and develop approaches how to reach these goals. By identifying which leadership style serves you best you will be able to develop every member in the most effective way.

Team Coaching

Team coaching aims to improve the functioning and productivity of an existing team. A successful and motivated team will
  • perceive and appreciate the unique dynamics in the group
  • discover one another's strengths
  • balanced use of existing resources
  • communicate effectively
  • work together in an atmosphere of mutual appreciation
  • develop a superior vision that serves the common good
Let’s turn your team into a "High Performance Team"!

Conflict Mediation

Team conflicts are emotionally strained situations for everybody involved and can impair the entire group performance. Same organizational conflicts may require the help of conflict mediation. Mediators act like communication facilitators in a session who guide the members in the process until an agreement is achieved. They do not make the decision but may provide ideas and suggest proposals.
As a conflict mediator I offer solutions in situations where there seems to be no way out.
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